DePuy Orthopaedics, Inc. recalls
Every recall we track for DePuy Orthopaedics, Inc. — 50 in all, from 2017–2024 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
Recalls from DePuy Orthopaedics, Inc. peaked in 2021 (22); 50 since 2017.
All FDA recall records for DePuy Orthopaedics, Inc. since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 3 | 5 | 0 | 8 |
| 2018 | 0 | 1 | 6 | 0 | 7 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 1 | 1 | 2 |
| 2021 | 0 | 13 | 9 | 0 | 22 |
| 2022 | 0 | 1 | 4 | 0 | 5 |
| 2023 | 0 | 0 | 4 | 1 | 5 |
| 2024 | 0 | 0 | 1 | 0 | 1 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2026 (to date) | 0 | 0 | 0 | 0 | 0 |
Most common reasons for DePuy Orthopaedics, Inc. recalls
What to do if you have a recalled DePuy Orthopaedics, Inc. product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All DePuy Orthopaedics, Inc. recalls
24 shown- Lower riskMedical device
DePuy Orthopaedics, Inc. recalls ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6. Component of the ATTUNE Total Knee
DePuy Orthopaedics recalls ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6 due to incorrect labeling. This component is part of the ATTUNE Total Knee Replacement System. No action is required as the labeling error does not affect safety.
DeP: OrthopaedicsMar 12, 2024 - Lower riskMedical device
DePuy Orthopaedics, Inc. recalls Attune Revision Limb Preservation System (LPS) Tibial Insert XXSM 18MM, Part Number 151760118
DePuy recalls Attune Revision Limb Preservation System Tibial Insert XXSM 18MM with higher radiation dose that may alter implant material. Affected units have specific part number and lot code.
DePuyFeb 15, 2023 - Use cautionMedical device
DePuy Orthopaedics, Inc. recalls ATTUNE Measured Sizing and Rotation Guide-to size the femur and align rotation of the bone cuts in preparation for the
DePuy recalls ATTUNE Measured Sizing and Rotation Guides made with incorrect steel spring that may corrode, causing surgical delays, debris, and joint issues. Affected units include specific lot numbers and part numbers.
DePuyJun 29, 2022 - Lower riskMedical device
DePuy Orthopaedics, Inc. recalls MODULAR CATHCART FRACTURE HEAD HIP BALL, sizes 41mm to 60mm inclusive; metallic femoral head prosthesis, Product No.
DePuy recalls hip implants with a +5mm offset not specified in instructions. This could affect surgical outcomes in hip replacements. Affected models include sizes 41mm-60mm with specific product numbers.
DePuyMay 18, 2022 - Lower riskMedical device
DePuy Orthopaedics, Inc. recalls VELYS Robotic-Assisted Solution Base Product No.: 451570100
DePuy recalls VELYS Robotic-Assisted Solution Base with software v1.5.1 that may cause system errors during DST changes, potentially delaying treatment. Affected units have specific serial numbers and UDI.
DePuyMar 11, 2022 - Lower riskMedical device
DePuy Orthopaedics, Inc. recalls ATTUNE REVISION POSTERIOR FEMORAL AUGMENT SZ 9 12MM-intended as a Component in total knee arthroplasty (TKA) revision
DePuy recalls ATTUNE revision posterior femoral augment (size 9 12mm) for possible adhesive residue causing soft tissue irritation or infection during knee surgery.
DePuyJan 5, 2022 - Use cautionMedical device
DePuy Orthopaedics, Inc. recalls GLOBAL UNITE REV STEM SZ 10 Product Code: 110010600
DePuy Orthopaedics recalls Global Unite Rev Stem SZ 10 implants with undersized spigot bore diameter that may require surgical delay or bone damage. Affected units sold globally with specific product code.
DePuyDec 7, 2021 - Lower riskMedical device
DePuy Orthopaedics, Inc. recalls ATTUNE Revision Tibial Augment Size 7/8 5mm- intended for knee joint replacement Part Code:152307001
DePuy recalls knee replacement implants with part code 152307001 due to potential surgery delays from improper screws. Affected units sold between 2020-2022.
DePuySep 9, 2021 - Use cautionMedical device
DePuy Orthopaedics, Inc. recalls TRUMATCH CT CUT GUIDE KIT L- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical
DePuy recalls TRUMATCH CT Cut Guide Kit L patient-specific surgical instruments due to a software error that may cause hip, knee or ankle misalignment during joint replacement surgery. Affected units have specific part numbers and GTINs.
DePuyAug 10, 2021 - Lower riskMedical device
DePuy Orthopaedics, Inc. recalls ATTUNE REVISION CEMENTED STEM 16X80MM-intended for use in total knee arthroplasty Part Number: 1512-16-080
DePuy recalls 16x80mm revision cemented knee stem (part 1512-16-080) due to incorrect size in shipment. Affected units may cause improper fit during surgery.
DePuyJul 1, 2021 - Lower riskMedical device
DePuy Orthopaedics, Inc. recalls DePuy Synthes Articul/eze Femoral Head: Hip joint metal/polymer semi-constrained cemented prosthesis. Part Number:
DePuy recalls 50 hip implants with wrong part number and size etched on product. Affected units may have incorrect dimensions causing improper fit.
DePuyMay 7, 2021 - Lower riskMedical device
DePuy Orthopaedics, Inc. recalls ATTUNE¿ FIXED BEARING KNEE - Product Usage: composed of individually packaged femoral, tibial and patellar components
DePuy recalls specific lots of ATTUNE fixed bearing knee implants due to potential damaged packaging. These components are used in total knee replacements and may pose risks during surgical procedures.
DePuyFeb 22, 2021 - Lower riskMedical device
DePuy Orthopaedics, Inc. recalls Universal Femoral Sleeves - Product Usage: used primarily in revision surgeries with the S-ROM Noiles, LPS, SIGMA, and
DePuy recalls Universal Femoral Sleeves used in revision knee surgeries due to potential taper dimension issues from manufacturing. Affected lots include J85Y90, J86T23, J86T20, J8790J, J85Y92. Contact for details.
DePuyJan 8, 2021 - Lower riskMedical device
DePuy Orthopaedics, Inc. recalls Pinnacle Cups, Part numbers 121701048 121701050 121701052 121701054 121701056 121701058 121701060 121701062 121711048
DePuy Orthopaedics is a leading manufacturer of surgical implants and medical devices for orthopedic procedures. Their products include joint replacements, spinal implants, and trauma devices.
DePuy OrthopaedicsDec 15, 2020 - UnratedMedical device
DePuy Orthopaedics, Inc. recalls SPECIALIST 2 DISTAL FEMORAL CUTTING BLOCK. Part code 966115. The product is a femoral cutting block.
DePuy recalls Specialist 2 Distal Femoral Cutting Blocks (part 966115) that won't connect to the Specialist 2 Locating Outrigger, making them unusable in surgery.
DePuyJan 3, 2020 - Lower riskMedical device
DePuy Orthopaedics, Inc. recalls CORAIL AMT STANDARD OFFSET NECK SEGMENT (STD), Pro. Code L20431 Product Usage: The affected CORAIL Neck Trials are
DePuy recalls certain CORAIL hip implants due to potential debris behind O-rings. Affected models include specific lot numbers for hip surgery instruments. Contact DePuy for details.
DePuySep 21, 2018 - Lower riskMedical device
DePuy Orthopaedics, Inc. recalls P.F.C. SIGMA Revision Knee System Distal Augment, Model Number 960830
DePuy recalls P.F.C. SIGMA Revision Knee System Distal Augment Model 960830 due to potential missing screw/collet assembly. Affected units may require repair or replacement.
DePuyJul 18, 2018 - Use cautionMedical device
DePuy Orthopaedics, Inc. recalls CORAIL Cementless Femoral Stem HA Coated Standard Size 11, Catalog No. 3L92511
DePuy Orthopaedics recalls cementless femoral stems labeled Size 11 but actually Size 12. This mismatch risks poor joint fit, loosening, and extra surgery. Affected units sold between 2018-2020.
DePuy OrthopaedicsJun 21, 2018 - Lower riskMedical device
DePuy Orthopaedics, Inc. recalls ATTUNE Revision CRS Femoral RT SZ 5 Cemented, Catalog No. 150440205, Femoral Revision Implant, Knee
DePuy recalls certain ATTUNE Revision CRS Femoral RT SZ 5 Cemented knee implants due to potential burrs on extraction hole threads. Affected units may require removal to prevent complications.
DePuyApr 16, 2018 - Lower riskMedical device
DePuy Orthopaedics, Inc. recalls (1) Sigma HP Cemented Trochlea Size 1 Narrow Left, Catalog Number: 102403100, GTIN: 10603295001614; (2) Sigma HP
DePuy recalls specific Sigma HP cemented trochlear implants due to higher-than-expected revision rates observed in post-market use. Affected products include left and right narrow sizes 1-5 with catalog numbers 102403100-102404500.
DePuyDec 21, 2017 - Lower riskMedical device
DePuy Orthopaedics, Inc. recalls The GLOBAL UNITE Platform Shoulder System is intended for cemented or uncemented total shoulder or hemi-shoulder
DePuy recalls specific lots of GLOBAL UNITE Platform Shoulder System due to screw inversion during assembly, potentially causing surgical delays. Affected patients should contact DePuy for guidance.
DePuyNov 28, 2017 - Lower riskMedical device
DePuy Orthopaedics, Inc. recalls DELTA XTEND" Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants intended for use in total
DePuy recalls Delta XTEND Reverse Shoulder System implants due to potential surgical delay from improper assembly. Affected lots include specific model numbers for shoulder replacement procedures.
DePuyAug 31, 2017 - Use cautionMedical device
DePuy Orthopaedics, Inc. recalls Concorde Lift Torque Limiting Handle. Must be used with supplemental internal spinal fixation systems that have been
DePuy Orthopaedics recalls Concorde Lift Torque Limiting Handles used in spinal surgery. Potential for intra-operative breakage of driver tips could cause complications during spinal procedures.
DePuy OrthopaedicsJul 26, 2017 - Lower riskMedical device
DePuy Orthopaedics, Inc. recalls CORAIL HIGH OFFSET STEM Collarless SIZE 14
DePuy recalls CORAIL HIGH OFFSET STEM Collarless Size 14 (Part No. L20314, Lot No. 5292130) due to incorrect product being shipped in the package. Consumers should check their order details.
DePuyJul 12, 2017
DePuy Orthopaedics, Inc. recall questions
How many recalls has DePuy Orthopaedics, Inc. had?
50 recalls from DePuy Orthopaedics, Inc. are on record with U.S. safety agencies, from 2017–2024.
What is the most recent DePuy Orthopaedics, Inc. recall?
DePuy Orthopaedics, Inc. recalls ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6. Component of the ATTUNE Total Knee, dated Mar 12, 2024. Every DePuy Orthopaedics, Inc. recall is listed on this page, newest first.
Why are DePuy Orthopaedics, Inc. products recalled?
The most common reasons on record: Potential for Intra-operative breakage of driver tips (2); There may be burrs on the extraction hole threads. (2).
What should I do if I have a recalled DePuy Orthopaedics, Inc. product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new DePuy Orthopaedics, Inc. recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.