The Recall Desk

Manufacturer

Synthes (USA) Products LLC

164 recalls in our database name Synthes (USA) Products LLC as the manufacturing or recalling firm.

What the numbers show

Total
164
Critical
0
Severe
22
Most recent
2026-04-08

Of the 164 recalls from Synthes (USA) Products LLC we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 22 (13%) 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.

1–25 of 164

  • HighFDA (Devices)·Z-1703-2026·2026-04-08

    VOLT bone taps swapped between lots carry the incorrect thread

    The 2.4 VOLT Tap Cortex Screw is being recalled after a full lot swap with the VOLT Locking Screw Tap left the bone taps with an incorrect thread.

    Product
    2.4 VOLT(TM) TAP CORTEX SCREW TO 90MM. Part Number: 03.424.126-US.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1702-2026·2026-04-08

    VOLT locking screw taps swapped between lots carry incorrect thread

    The 2.4 VOLT Tap Locking Screw Tap is being recalled after a full lot swap with the Cortical Screw Tap left the bone taps with an incorrect thread.

    Product
    2.4 VOLT TAP LOCKING SCREW TAP TO 90MM. Part Number: 03.424.124-US.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0229-2026·2025-10-29

    Locking bone screws recalled after packaging labeled with the wrong length

    Synthes is recalling 122 low profile locking screws because 42mm screws were packaged and labeled as 46mm and 46mm screws were labeled as 42mm, though the etched length is correct.

    Product
    LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 42MM / XL25/ STER. Product Code: 04.045.342TS. Used in RFN-ADVANCEDTM Retrograde Femoral Nailing (RFNA) System and the Tibial Nail Advanced System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0228-2026·2025-10-29

    Forty six millimetre locking screws recalled over wrong length on packaging

    Synthes is recalling 120 low profile locking screws because 42mm screws were packaged and labeled as 46mm and 46mm screws were labeled as 42mm, though the etched length is correct.

    Product
    LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 46MM / XL25/ STER. Product Code: 04.045.346TS. Used in RFN-ADVANCEDTM Retrograde Femoral Nailing (RFNA) System and the Tibial Nail Advanced System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1916-2024·2024-06-05

    Surgical screwdrivers recalled for failure to engage with implant screws

    Synthes surgical screwdrivers are being recalled because they lack a required relief cut and will not engage properly with 1.3mm and 1.5mm implant screws, potentially delaying surgery. The defect affects 261 units distributed in the US and Canada.

    Product
    STARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/HXC-Intended for tightening, loosening, or removing of screw implants during orthopaedic surgery. Part Number: 03.130.010
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1240-2024·2024-03-13

    TFNA Femoral Nail Recalled Due to Sterility Confirmation Issue

    Synthes is recalling 11 TFNA Femoral Nails due to sterility failures. The affected units worldwide cannot be confirmed as sterilized and pose infection risks to patients.

    Product
    TFNA Femoral Nail 11mm, right, 130¿, L 235mm-Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.144S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1239-2024·2024-03-13

    TFNA Femoral Nail surgical implant recalled for sterility failure

    Synthes (USA) Products LLC is recalling 11 TFNA Femoral Nails (Lot 3744P37) because the products are not sterilized or sterility cannot be confirmed, posing infection risk.

    Product
    TFNA Femoral Nail 9mm, right, 130¿, L 235mm-Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.944S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1242-2024·2024-03-13

    Synthes Opal Intervertebral Cage Spinal Implant Recall: Sterility Not Confirmed

    Synthes is recalling 30 Opal intervertebral cage spinal implants (Lot 427P153) because sterility cannot be confirmed. Patients with these devices should contact their surgeon immediately.

    Product
    Opal, Intervertebral Cage, 10x32mm, h 11mm, Revolvable-Indicated for degenerative spine disease Part Number: 08.803.231S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1236-2024·2024-03-13

    Synthes 2.5MM Surgical Drill Bits Recalled Due to Unconfirmed Sterility

    Synthes (USA) Products LLC is recalling 30 units of 2.5MM sterile surgical drill bits (Lot 77P6506) because sterility cannot be confirmed. Non-sterile surgical instruments pose a risk of surgical site infection if used in orthopedic procedures.

    Product
    2.5MM DRILL BIT/QC/GOLD/110MM STERILE-surgical, orthopedic, pneumatic powered & accessory/attachment Product Code: 310.25S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1238-2024·2024-03-13

    RAPIDSORB IPS Battery Pack recalled due to unconfirmed sterility

    Synthes is recalling 10 units of RAPIDSORB IPS Battery Pack Sterile because the products cannot be confirmed as sterile. The affected lot was distributed worldwide to medical facilities. Patients should consult their healthcare provider about replacement options.

    Product
    RAPIDSORB IPS Battery Pack, Sterile-Intended for use in non-load bearing fracture repair and reconstructive procedures of the craniofacial skeleton (excluding the upper and lower jaw) in pediatric and adult populations. Part Number: 530.553.01S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1237-2024·2024-03-13

    Synthes RIA Tube Assembly Recalled for Unconfirmed Sterility

    Synthes is recalling 144 units of RIA Tube Assembly surgical instruments due to sterility failure. The devices cannot be confirmed as sterile and pose a risk of infection if used in orthopedic procedures.

    Product
    RIA Tube Assembly, minimum 520 mm length, sterile- intended for use in adults and adolescents (12-21 years) to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis, to harves
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1241-2024·2024-03-13

    Synthes Clavicle Plate Implants Recalled Due to Sterility Failure

    Synthes is recalling 47 VA-LCP Clavicle Plate 2.7 bone fixation implants (Lot 1201P12) distributed worldwide because sterility cannot be confirmed. Non-sterile surgical implants pose risk of infection.

    Product
    VA-LCP Clavicle Plate 2.7, shaft, CS1, right-Intended for fixation of clavicle bone fragments. Part Number: 02.112.621S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1235-2024·2024-03-13

    Synthes 1.5MM Surgical Drill Bit Recalled Due to Sterilization Concerns

    Synthes has recalled 17 units of 1.5MM surgical drill bits worldwide because the products could not be confirmed as sterilized, posing an infection risk during orthopedic procedures.

    Product
    1.5MM Drill Bit/QC/85MM Sterile-surgical, orthopedic, pneumatic powered & accessory/attachment Part Number: 310.15S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1234-2024·2024-03-13

    Titanium Hindfoot Arthrodesis Cannulated Nails Recalled Due to Sterilization Failure

    Synthes recalls 13 mm Titanium Hindfoot Arthrodesis Cannulated Nails (5 units) due to failed sterilization. These surgical implants were distributed worldwide and pose infection risk if implanted.

    Product
    13 mm Titanium Hindfoot Arthrodesis Cannulated Nails EX, sterile -Intended to facilitate tibiotalocalcaneal arthrodesis to treat severe foot/ankle deformity, arthritis, instability, and skeletal defects after tumor resection. Part Number: 04.008.378S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1246-2023·2023-03-22

    Synthes TFN-Advanced Femoral Nail Recalled for Dimensional Labeling Mismatch

    Synthes (USA) Products LLC is recalling TFN-Advanced Femoral Nails because labeled measurements do not match actual dimensions. Nails labeled 200mm may be 170mm and vice versa.

    Product
    TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 200MM STERILE. Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.213S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1248-2023·2023-03-22

    TFN Femoral Nails dimensions mislabeled, may measure 170mm or 200mm

    Synthes recalled TFN-Advanced Femoral Nails because some units have incorrect dimensions: nails labeled 200mm may measure 170mm, while those labeled 170mm may measure 200mm. This dimensional mismatch could compromise surgical fixation.

    Product
    TFN-Advanced Femoral Nail 12MM/130 DEG TI CANN TFNA 170MM STERILE. Intended for temporary fixation and stabilization of proximal femur fractures Part Number: 04.037.242S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1247-2023·2023-03-22

    TFN-Advanced Femoral Nails May Have Incorrect Length Markings

    Synthes TFN-Advanced Femoral Nails labeled as 200mm may measure 170mm, and vice versa. Healthcare providers should verify actual dimensions before surgical use.

    Product
    TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 170MM - STERILE. Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.212S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0098-2023·2022-10-26

    Synthes Orthopedic Implant Drill Kit Recall: Incorrect Drill Guide Size

    Synthes (USA) Products LLC is recalling 81 SPEEDSHIFT20x20x20 Offset 10mm Implant Drill Kits nationwide due to incorrect drill guide sizing. The defect could result in bone damage and incorrectly placed drill holes during orthopedic surgery.

    Product
    SPEEDSHIFT20x20x20 Offset 10mm Implant Drill Kit, Product No. SE-2020-10. Used with DePuy Synthes SPEEDSHIFT Continuous Compression Staple Implants for bone fixation and management of fracture and reconstructive surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0100-2023·2022-10-26

    Synthes SPEED implant recall: drill guide size mismatch in surgical kit

    Synthes is recalling SPEED 9X10X10mm surgical implant kits nationwide due to an incorrect-size drill guide that will not properly prepare bone for the implant, creating potential for bone damage.

    Product
    SPEED 9X10X10mm Continuous Compression Implant, Product No. SE-0910
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0101-2023·2022-10-26

    DePuy Synthes Hammertoe Implants Recalled for Incorrect Drill Guide Size

    Synthes (USA) Products LLC is recalling 196 DePuy Synthes Hammertoe Continuous Compression Implants due to an incorrect drill guide size that will not properly prepare bone for the implant, creating potential for bone damage.

    Product
    DePuy Synthes Hammertoe Continuous Compression Implants, Product No. 46.239.001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0099-2023·2022-10-26

    Surgical Implant Kit Recall: Incorrect Drill Guide Included

    Synthes surgical implant kits are being recalled because they contain an incorrect size drill guide that cannot properly prepare the bone for the implant, creating a risk of bone damage during surgery.

    Product
    SPEED 15X12X12mm Continuous Compression Implant, Product No. SE-1512
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0008-2023·2022-10-12

    Hammertoe Continuous Compression Implant Kit Drill Pin Incompatibility

    Synthes is recalling Hammertoe Continuous Compression Implant (CCI) Kits because the drill pin is incompatible with the included drill template, which may delay surgery or cause soft tissue damage and adverse tissue reactions.

    Product
    Hammertoe Continuous Compression Implant (CCI) Kit Part Number: 46.239.001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1072-2022·2022-05-18

    Radial Head Replacement System implant: contraindications added to safety instructions

    Synthes has updated safety instructions for its Radial Head Replacement System implant with absolute contraindications for use in patients with infection, sepsis, or osteomyelitis. The FDA has classified this as a Class II recall.

    Product
    Radial Head Replacement System Implant is a one-piece, stemmed radial head replacement. The radial head is available in diameters of 19, 22 and 25mm. The radial stems range from 5.5 to 8.5mm in diameter and from 21 24mm in length.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0634-2022·2022-02-16

    Universal Chuck Surgical Instrument Handle May Detach and Release Ball Bearings

    The Universal Chuck instrument handle may loosen and release ball bearings onto the surgical field. If not recovered, these bearings could delay surgery and potentially cause infection or tissue damage.

    Product
    Universal Chuck-The Universal Chuck is an Instrument Handle provided as an alternative instrument available for use in the TN-ADVANCED" Tibial Nailing System (TNA), TFN-ADVANCED" Proximal Femoral Nailing System (TFNA), RFN-ADVANCED" Retrograde Femoral Nailing System (RFNA), FRN-A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0571-2021·2020-12-23

    DePuy Synthes 10.0MM Reamer Head Recalled for Breakage and Tissue Damage

    Synthes (USA) Products LLC is recalling DePuy Synthes 10.0MM Reamer Heads for RIA 2 because breakage exceeds expected rates, causing potential tissue or bone damage.

    Product
    DePuy Synthes 10.0MM REAMER HEAD FOR RIA 2, STERILE-Orthopedic manual surgical instrument Part Code: 03.404.016S
    Category
    Medical Device
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Synthes

company

Country
Switzerland
Founded
1954
Parent company
Johnson & Johnson

Official website

Source: Wikidata (Q503072), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.