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.

101–125 of 155

HighFDA (Devices)·Z-0416-2014·2013-12-04
DePuy Recalls HP M.B.T. Keel Punch Knee Instruments Due to Fracture Risk
DePuy Orthopaedics is recalling HP M.B.T. Keel Punch Knee Instruments because tabs on the connection end may fracture and remain in the patient.
Product
SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT KEEL PUNCH NONCEMENTED Size 2-3 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0064-2014·2013-10-30
DePuy SmartSet GMV Endurance Gentamicin Bone Cement Recalled for Uncleared Indications
DePuy Orthopaedics is recalling SmartSet GMV Endurance Gentamicin Bone Cement because it is intended for uses not cleared by the FDA.
Product
SmartSet¿ Endurance GMV, Gentamicin, REF 3105-040, Medium Viscosity Antibiotic Bone Cement, Sterile. SmartSet GMV Endurance Gentamicin, bone cements are self-curing, radiopaque, polymethyl methacrylate based cements, containing antibiotic, used for securing a metal or polymer
Category
Medical Device
Distribution
2 states
CriticalFDA (Devices)·Z-1820-2013·2013-08-07
DePuy LPS Lower Extremity Dovetail Intercalary Component Recall for Fracture Risk
DePuy Orthopaedics is recalling LPS Lower Extremity Dovetail Intercalary components due to a potential for fracture under certain physiological loads.
Product
LPS Lower Extremity Dovetail Intercalary component. Intended for use in replacement of the mid-shaft portion of the femur.
Category
Medical Device
Distribution
17 states
HighFDA (Devices)·Z-1520-2013·2013-06-19
DePuy Glenosphere Orientation Guide Recalled for Incorrect Etched Arrow Placement
DePuy Orthopaedics is recalling Glenosphere orientation guides because an etched arrow is on the wrong side, which could lead to incorrect implant alignment.
Product
DePuy Glenosphere orientation guide Product Usage: The glenosphere orientation guide is an instrument used in reverse shoulder arthroplasty. The orientation guide is used to properly align the glenosphere.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1366-2013·2013-05-29
DePuy Recalls AltrX Hip Liners Due to Incorrect Box Labeling
DePuy Orthopaedics is voluntarily recalling 20 AltrX Polyethylene Acetabular Liners because the boxes were incorrectly labeled with the wrong product specifications.
Product
Pinnacle Hip Solutions ALTRX Polyethylene Acetabular Liner, Ref 1221-36-452 Product Usage: An acetabular liner is used in combination with other implants for total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1331-2013·2013-05-22
DePuy LifeLiner Gloves Recalled for Mispackaging
DePuy Orthopaedics is recalling LifeLiner Stick and Cut Resistant Gloves because right-handed packages contained left-handed gloves.
Product
DePuy LifeLiner Stick & Cut Resistant Gloves Rt, Lg Part No. 5200-68-000 The gloves are designed to resist sticks and cuts and are not cut or puncture proof. These gloves are not required by any surgical technique.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0971-2013·2013-03-27
DePuy Specialist 2 IM Rod Recalled for Potential Breakage Risk
DePuy Orthopaedics is recalling Specialist 2 IM Rods and associated surgical techniques due to a potential risk of the rod breaking and leaving fragments in patients.
Product
Specialist 2 IM Rod, Non-Sterile and associated Surgical Techniques: Sigma HP Instruments Classic Surgical Technique,0612-89-510 Sigma HP Instruments Balanced Surgical Technique, 0612-88-510 Sigma HP Instruments Fixed Reference Surgical Technique, 0612-87-510 PFC Sigma Knee
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0972-2013·2013-03-27
DePuy ReClaim Reamer Extension Recalled Due to Broken Tabs
DePuy Orthopaedics is recalling 750 ReClaim Reamer Extension devices because tabs may break and remain in patients during surgery.
Product
ReClaim Reamer Extension; Product code 2975-00-500, used with Reclaim Modular Revision Hip Prosthesis System. The ReClaim Reamer Extension is as an attachment to the distal reamers to allow the surgeon to clear soft tissue while reaming the distal femoral canal.
Category
Medical Device
Distribution
27 states
SevereFDA (Devices)·Z-0828-2013·2013-02-27
DePuy LPS Diaphyseal Sleeves Recalled for Potential Taper Fracture
DePuy Orthopaedics is voluntarily recalling LPS Diaphyseal Sleeves because the taper connection may fracture under normal gait loads.
Product
LPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are used with the LPS System which is an end-stage revision knee product that allows surgeons to reconstruct severe soft tissue and bony defects.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0831-2013·2013-02-27
DePuy LPS Diaphyseal Sleeves Recalled for Potential Fracture Risk
DePuy Orthopaedics is voluntarily recalling LPS Diaphyseal Sleeves due to a potential fracture risk at the taper junction during normal gait activities.
Product
LPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are used with the LPS System which is an end-stage revision knee product that allows surgeons to reconstruct severe soft tissue and bony defects.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0829-2013·2013-02-27
DePuy LPS Diaphyseal Sleeves Recalled for Potential Taper Fracture
DePuy Orthopaedics is voluntarily recalling LPS Diaphyseal Sleeves because the taper connection may fracture under normal physiologic loads.
Product
LPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are used with the LPS System which is an end-stage revision knee product that allows surgeons to reconstruct severe soft tissue and bony defects.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0830-2013·2013-02-27
DePuy LPS Diaphyseal Sleeves Recalled for Potential Taper Fracture
DePuy Orthopaedics is voluntarily recalling LPS Diaphyseal Sleeves because the taper connection may fracture under normal gait loads.
Product
LPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are used with the LPS System which is an end-stage revision knee product that allows surgeons to reconstruct severe soft tissue and bony defects.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0574-2013·2012-12-26
DePuy Orthopaedics Recalls Solution Calcar Stems Due to Impingement Risk
DePuy Orthopaedics is recalling Solution Calcar Stems used in hip replacements because an engineering analysis found they may impinge with certain heads, preventing them from locking as intended.
Product
SOL SYS F 8 CALC 13.5MM LG 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
SevereFDA (Devices)·Z-0577-2013·2012-12-26
DePuy Solution Calcar Stems Recalled Due to Potential Impingement
DePuy Orthopaedics is recalling Solution Calcar Stems because an engineering analysis found they may impinge with certain heads, preventing them from locking as intended.
Product
SOL SYS 8IN CALC 1.5/18.0 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 for
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0581-2013·2012-12-26
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 heads.
Product
SOL SYS L 9IN CALC 2.25/16.5 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
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0590-2013·2012-12-26
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 heads.
Product
SOL SYS R 9IN CALC 2.25/19.5 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
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0585-2013·2012-12-26
DePuy Solution Calcar Stem Recalled for Potential Impingement
DePuy Orthopaedics is recalling Solution Calcar Stems because engineering analysis found they may impinge with certain heads, preventing proper locking.
Product
SOL SYS L 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-0588-2013·2012-12-26
DePuy Solution Calcar Stems Recalled Due to Potential Impingement
DePuy Orthopaedics is recalling Solution Calcar Stems because engineering analysis found they may impinge with certain heads, preventing proper locking.
Product
SOL SYS R 9IN CALC 2.25/16.5 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
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0586-2013·2012-12-26
DePuy Orthopaedics Recalls Solution Calcar Stems Due to Impingement Risk
DePuy Orthopaedics is recalling Solution Calcar Stems used in hip replacements because an engineering analysis found they may not lock properly with certain heads.
Product
SOL SYS F 9 CALC L 13.5MM LG 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-0575-2013·2012-12-26
DePuy Solution Calcar Stems Recalled for Potential Impingement
DePuy Orthopaedics is recalling Solution Calcar Stems used in hip replacements because engineering analysis found they may not lock properly with certain heads.
Product
SOL SYS 8IN CALC 1.5/15.0 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 for
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0579-2013·2012-12-26
DePuy Solution Calcar Stem Recalled for Potential Impingement
DePuy Orthopaedics is recalling Solution Calcar Stems used in hip replacements because engineering analysis found they may not lock properly with certain heads.
Product
SOL SYS F 9 CALC L 13.5MM LG 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-0580-2013·2012-12-26
DePuy Solution Calcar Stems Recalled Due to Potential Impingement
DePuy Orthopaedics is recalling Solution Calcar Stems used in hip replacements because engineering analysis found they may not lock properly with certain heads.
Product
SOL SYS L 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-0583-2013·2012-12-26
DePuy Orthopaedics Recalls Solution Calcar Stems Due to Impingement Risk
DePuy Orthopaedics is recalling 1,732 Solution Calcar Stems because engineering analysis found they may not lock properly with certain femoral heads, posing a risk of impingement.
Product
SOL SYS L 9IN CALC 2.25/19.5 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
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0589-2013·2012-12-26
DePuy Solution Calcar Stems Recalled Due to Potential Impingement
DePuy Orthopaedics is recalling Solution Calcar Stems because engineering analysis found they may impinge with certain heads, preventing proper locking.
Product
SOL SYS R 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-0584-2013·2012-12-26
DePuy Orthopaedics Recalls Solution Calcar Stems Due to Impingement Risk
DePuy Orthopaedics is recalling Solution Calcar Stems because an engineering analysis found they may impinge with certain heads, preventing proper locking.
Product
SOL SYS L 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