Manufacturer

DePuy Orthopaedics, Inc.

155 recalls in our database name DePuy Orthopaedics, Inc. as the manufacturing or recalling firm.

What the numbers show

Total: 155
Critical: 1
Severe: 23
Most recent: 2024-04-10

Of the 155 recalls from DePuy Orthopaedics, Inc. we have scored against our rubric, 1 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 23 (15%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

126–150 of 155

HighFDA (Devices)·Z-0582-2013·2012-12-26
DePuy Solution Calcar Stems Recalled Due to Potential Impingement
DePuy Orthopaedics is recalling Solution Calcar Stems used in hip replacements because an engineering analysis found they may not lock as intended with certain femoral heads.
Product
SOL SYS L 9IN CALC 2.25/18 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray fo
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0592-2013·2012-12-26
DePuy Solution Calcar Stem Recalled for Potential Impingement
DePuy Orthopaedics is recalling Solution Calcar Stems because an engineering analysis found they may impinge with certain heads, preventing proper locking.
Product
SOL SYS R 9IN CALC 2.25/22.5 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0573-2013·2012-12-26
DePuy Solution Calcar Stem Recalled for Potential Impingement
DePuy Orthopaedics is recalling Solution Calcar Stems because an engineering analysis found they may not lock properly with certain femoral heads.
Product
SOL SYS 8IN CALCAR SZ12 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray for a
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0578-2013·2012-12-26
DePuy Orthopaedics Recalls Solution Calcar Stems Due to Impingement Risk
DePuy Orthopaedics is recalling Solution Calcar Stems used in hip replacements because engineering analysis found they may not lock properly with certain femoral heads.
Product
SOL SYS 8IN CALC 1.5/19.5 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray for
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0576-2013·2012-12-26
DePuy Solution Calcar Stem Recalled for Potential Impingement
DePuy Orthopaedics is recalling Solution Calcar Stems because engineering analysis found they may impinge with certain femoral heads, preventing the stem and head from locking as intended.
Product
SOL SYS 8IN CALC 1.5/16.5 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray for
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0587-2013·2012-12-26
DePuy Solution Calcar Stems Recalled for Potential Impingement
DePuy Orthopaedics is recalling Solution Calcar Stems used in hip replacements because an engineering analysis found they may impinge with certain heads, preventing them from locking as intended.
Product
SOL SYS R 9IN CALC 2.25/15.0 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0591-2013·2012-12-26
DePuy Solution Calcar Stem Recalled for Potential Impingement
DePuy Orthopaedics is recalling Solution Calcar Stems because an engineering analysis found they may impinge with certain heads, preventing proper locking.
Product
SOL SYS R 9IN CALC 2.25/21 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray fo
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0569-2013·2012-12-26
DePuy Recalls Pinnacle Cancellous Screws Due to Labeling Error
DePuy Orthopaedics is recalling 118 Pinnacle Cancellous Screws because the labels incorrectly identify them as Cannulated Screws.
Product
Pinnacle Cancellous Screw Packaging: Product is housed within a polyurethane protector; this is placed inside an uncoated Tyvek/PET peel pouch and sealed. This package is placed into a paperboard carton, labeled and shrink-wrapped. PINNACLE¿ CANCELLOUS Bone Screws are ancil
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2414-2012·2012-09-26
DePuy S-ROM Total Hip System Poly Liner Recalled for Labeling Error
DePuy Orthopaedics is voluntarily recalling four lots of S-ROM Total Hip System Poly Liners because the carton labels contain an incorrect color code series designation.
Product
S-Rom¿ Total Hip System Poly Liner Packaging: The insert is placed into an inner foil pouch and vacuum sealed; a ring is placed into a Tyvek/PET pouch and sealed; the foil pouch and Tyvek/PET pouch are placed into a nylon outer pouch and sealed. This is then placed into a f
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2220-2012·2012-08-29
DePuy Altralinked Polyethylene Liners Recalled for Incorrect Size Labeling
DePuy Orthopaedics is recalling 20 Altralinked polyethylene liners because a size 52 liner was incorrectly labeled as size 54.
Product
Altrx" Altralinked" Polyethylene liners Description: An acetabular liner is one of the implants used during total hip arthroplasty to replace the damaged hip joint to help increase patient mobility and to reduce pain. Packaging: Product is placed into a PETG tray, sealed with
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-2217-2012·2012-08-22
DePuy Orthopaedics Recalls Unimplanted Custom Implant Devices
DePuy Orthopaedics is retrieving 8,338 custom implant devices that were ordered but not implanted, following an FDA Warning Letter.
Product
DePuy Custom Implant Devices Packaging: Packaging was not standardized on customs, it was dependant on the geometry of the product Product Usage: Description: Devices meeting the regulatory definition of a custom medical device are those which are provided by prescriptio
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1923-2012·2012-07-11
DePuy Recalls Luster Hip Stems Implanted with Metal-on-Metal Articulations
DePuy Orthopaedics is issuing a Field Safety Notice for Luster and Ultima LX hip stems implanted with metal-on-metal articulations.
Product
LUSTER HIP SZ 9 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1914-2012·2012-07-11
DePuy Orthopaedics Recalls ULTIMA LX and LUSTER Hip Stems
DePuy Orthopaedics is recalling ULTIMA LX and LUSTER cemented polished femoral hip stems implanted with metal-on-metal articulations due to a field safety notice.
Product
ULTIMA*LX STM,POL 10/12TAP/4M Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system was
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1915-2012·2012-07-11
DePuy Recalls Luster and Ultima Hip Stems Implanted with Metal-on-Metal
DePuy Orthopaedics is issuing a Field Safety Notice for Luster and Ultima hip stems implanted with metal-on-metal articulations.
Product
LUSTER HIP SZ 1 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1924-2012·2012-07-11
DePuy Luster and Ultima Hip Stems Recalled for Metal-on-Metal Use
DePuy Orthopaedics is recalling Luster and Ultima hip stems implanted with metal-on-metal articulations due to a field safety notice.
Product
LUSTER HIP SZ 10 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1918-2012·2012-07-11
DePuy Recalls Luster Hip Stems Implanted with Metal-on-Metal Articulations
DePuy Orthopaedics is issuing a Field Safety Notice for Luster and Ultima LX hip stems implanted with metal-on-metal articulations.
Product
LUSTER HIP SZ 4 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1910-2012·2012-07-11
DePuy Orthopaedics Recalls ULTIMA LX and LUSTER Hip Stems
DePuy Orthopaedics is issuing a Field Safety Notice for ULTIMA LX and LUSTER Cemented Polished Femoral Hip Stems implanted with metal-on-metal articulations.
Product
ULTIMA*LX STM,POL 10/12TAP/SZ5 Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system wa
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1911-2012·2012-07-11
DePuy Orthopaedics Recalls ULTIMA LX and LUSTER Hip Stems
DePuy Orthopaedics is recalling ULTIMA LX and LUSTER Cemented Polished Femoral Hip Stems implanted with metal-on-metal articulations due to a Field Safety Notice.
Product
ULTIMA*LX STM,POL 10/12TAP/1M Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system was
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1922-2012·2012-07-11
DePuy Luster Hip Stems Recalled for Metal-on-Metal Articulation Concerns
DePuy Orthopaedics is recalling Luster and Ultima LX hip stems implanted with metal-on-metal articulations due to a field safety notice.
Product
LUSTER HIP SZ 8 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1917-2012·2012-07-11
DePuy Luster Hip Stems Recalled for Metal-on-Metal Articulation Concerns
DePuy Orthopaedics is issuing a Field Safety Notice for Luster and Ultima LX hip stems implanted with metal-on-metal articulations.
Product
LUSTER HIP SZ 3 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are fo
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1913-2012·2012-07-11
DePuy Recalls Cemented Polished Femoral Hip Stems Implanted with Metal-on-Metal Articulations
DePuy Orthopaedics is issuing a Field Safety Notice for LUSTER and ULTIMA LX Cemented Polished Femoral Hip Stems implanted with metal-on-metal articulations.
Product
ULTIMA*LX STM,POL 10/12TAP/3M Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system was
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1912-2012·2012-07-11
DePuy Recalls Cemented Polished Femoral Hip Stems Due to Metal-on-Metal Use
DePuy Orthopaedics is issuing a Field Safety Notice for LUSTER and ULTIMA LX Cemented Polished Femoral Hip Stems implanted with metal-on-metal articulations.
Product
ULTIMA*LX STM,POL 10/12TAP/2M Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system was
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1907-2012·2012-07-11
DePuy Orthopaedics Recalls ULTIMA LX and LUSTER Hip Stems
DePuy Orthopaedics is issuing a Field Safety Notice for ULTIMA LX and LUSTER Cemented Polished Femoral Hip Stems implanted with metal-on-metal articulations.
Product
ULTIMA*LX STM,POL 10/12TAP/SZ2 Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system wa
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1920-2012·2012-07-11
DePuy Luster Hip Stems Recalled for Metal-on-Metal Articulation Use
DePuy Orthopaedics is issuing a Field Safety Notice for Luster and Ultima LX hip stems implanted with metal-on-metal articulations.
Product
LUSTER HIP SZ 6 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1906-2012·2012-07-11
DePuy Orthopaedics Recalls ULTIMA LX and LUSTER Hip Stems
DePuy Orthopaedics is recalling ULTIMA LX and LUSTER hip stems implanted with metal-on-metal articulations due to potential safety concerns.
Product
ULTIMA*LX STM,POL 10/12TAP/SZ1 Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system wa
Category
Medical Device
Distribution
Distributed nationwide