DePuy Orthopaedics, Inc.
Complete recall history across all FDA and CPSC categories — 154 total recalls
DePuy Orthopaedics, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (154)
FDA medical device enforcement actions by DePuy Orthopaedics, Inc.. Showing most recent 50.
| Date | Product | Reason | Class |
|---|---|---|---|
| Mar 12, 2024 | ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6. Co... | Product incorrectly labelled. | Class II |
| Feb 15, 2023 | Attune Posterior (PS) Fixed Bearing (FB) Tibial Insert SZ5 7MM, Part Number 1... | The subject product lots are being recalled because they received a higher th... | Class II |
| Feb 15, 2023 | Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 26MM, Part N... | The subject product lots are being recalled because they received a higher th... | Class II |
| Feb 15, 2023 | Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 12MM, Part N... | The subject product lots are being recalled because they received a higher th... | Class II |
| Feb 15, 2023 | Attune Revision Limb Preservation System (LPS) Tibial Insert SM 12MM, Part Nu... | The subject product lots are being recalled because they received a higher th... | Class II |
| Feb 15, 2023 | Attune Revision Limb Preservation System (LPS) Tibial Insert XXSM 18MM, Part ... | The subject product lots are being recalled because they received a higher th... | Class II |
| Jun 29, 2022 | ATTUNE Measured Sizing and Rotation Guide-to size the femur and align rotatio... | Manufactured with a Galvanized High Carbon Steel spring instead of the correc... | Class II |
| May 18, 2022 | MODULAR CATHCART FRACTURE HEAD HIP BALL, sizes 41mm to 60mm inclusive; metall... | The Cathcart Ball has an inherent +5mm offset which is not currently specifie... | Class II |
| Mar 11, 2022 | VELYS Robotic-Assisted Solution Base Product No.: 451570100 | System software v1.5.1 has a system software issue related to the Daylight Sa... | Class II |
| Jan 5, 2022 | ATTUNE REVISION DISTAL FEMORAL AUGMENT SZ 6 4MM- Intended as a Component in t... | May have adhesive residue on the posterior surface of the femoral augment, if... | Class II |
| Jan 5, 2022 | ATTUNE REVISION POSTERIOR FEMORAL AUGMENT SZ 9 12MM-intended as a Component ... | May have adhesive residue on the posterior surface of the femoral augment, if... | Class II |
| Dec 7, 2021 | GLOBAL UNITE STD STEM SZ 8 Part Number: 110008100 | Stems may have an undersized spigot bore diameter therefore separating the pr... | Class II |
| Dec 7, 2021 | GLOBAL UNITE STD STEM SZ 6 Part Number: 11000610 | Stems may have an undersized spigot bore diameter therefore separating the pr... | Class II |
| Dec 7, 2021 | GLOBAL UNITE STD STEM SZ 14 Product Code: 110014100 | Stems may have an undersized spigot bore diameter therefore separating the pr... | Class II |
| Dec 7, 2021 | GLOBAL UNITE REV STEM SZ 8 Part Number: 110008600 | Stems may have an undersized spigot bore diameter therefore separating the pr... | Class II |
| Dec 7, 2021 | GLOBAL UNITE STD STEM SZ 12 Product Code: 110012100 | Stems may have an undersized spigot bore diameter therefore separating the pr... | Class II |
| Dec 7, 2021 | GLOBAL UNITE STD STEM SZ 10 Part Number: 110010100 | Stems may have an undersized spigot bore diameter therefore separating the pr... | Class II |
| Dec 7, 2021 | GLOBAL UNITE STD STEM SZ 16 Product Code: 110016100 | Stems may have an undersized spigot bore diameter therefore separating the pr... | Class II |
| Dec 7, 2021 | GLOBAL UNITE REV STEM SZ 10 Product Code: 110010600 | Stems may have an undersized spigot bore diameter therefore separating the pr... | Class II |
| Sep 9, 2021 | ATTUNE Revision Tibial Augment Size 7/8 5mm- intended for knee joint replacem... | Packaging may include screws that are not intended to be used with the 5mm au... | Class II |
| Aug 10, 2021 | TRUMATCH CT PIN GUIDE KIT L- TruMatch Patient Specific Instruments are inten... | Software: A coding error associated with the Fast3D Segmentation software. D... | Class II |
| Aug 10, 2021 | TRUMATCH CT CUT GUIDE KIT R- TruMatch Patient Specific Instruments are intend... | Software: A coding error associated with the Fast3D Segmentation software. D... | Class II |
| Aug 10, 2021 | TRUMATCH CT CUT GUIDE FEM L- TruMatch Patient Specific Instruments are intend... | Software: A coding error associated with the Fast3D Segmentation software. D... | Class II |
| Aug 10, 2021 | TRUMATCH CT PIN GUIDE FEM R- TruMatch Patient Specific Instruments are intend... | Software: A coding error associated with the Fast3D Segmentation software. D... | Class II |
| Aug 10, 2021 | TRUMATCH CT FEM CUT TIB PIN R- TruMatch Patient Specific Instruments are inte... | Software: A coding error associated with the Fast3D Segmentation software. D... | Class II |
| Aug 10, 2021 | TRUMATCH CT PIN GUIDE KIT R- TruMatch Patient Specific Instruments are intend... | Software: A coding error associated with the Fast3D Segmentation software. D... | Class II |
| Aug 10, 2021 | TRUMATCH CT CUT GUIDE KIT L- TruMatch Patient Specific Instruments are intend... | Software: A coding error associated with the Fast3D Segmentation software. D... | Class II |
| Jul 1, 2021 | ATTUNE REVISION CEMENTED STEM 16X80MM-intended for use in total knee arthropl... | Package labeled as 16mm x 80mm contained a 16mm x 130mm stem instead and resu... | Class II |
| May 7, 2021 | DePuy Synthes Articul/eze Femoral Head: Hip joint metal/polymer semi-constrai... | Fifty (50) individual units from Lot D20111130 were distributed with the inco... | Class II |
| Feb 22, 2021 | The LCS COMPLETE P.F.C.TM SIGMA RP Mobile Bearing Total Knee System - Produc... | Globally the company is removing 37 lots affected lots for MBT & ATTUNE (S+) ... | Class II |
| Feb 22, 2021 | The ATTUNE¿ Rotating Platform (RP) Total Knee System - Product Usage: consist... | Globally the company is removing 37 lots affected lots for MBT & ATTUNE (S+) ... | Class II |
| Feb 22, 2021 | ATTUNE¿ FIXED BEARING KNEE - Product Usage: composed of individually package... | Globally the company is removing 37 lots affected lots for MBT & ATTUNE (S+) ... | Class II |
| Jan 8, 2021 | Universal Femoral Sleeves - Product Usage: used primarily in revision surgeri... | The taper dimensions may be out of specification due to a production issue du... | Class II |
| Dec 15, 2020 | Pinnacle Cups, Part numbers 121701048 121701050 121701052 121701054 121701056... | Certain Pinnacle Cup devices may potentially exhibit an oversized "minor diam... | Class II |
| Jan 3, 2020 | SPECIALIST 2 DISTAL FEMORAL CUTTING BLOCK. Part code 966115. The product i... | The device will not connect to the Specialist 2 Locating Outrigger which rend... | Class II |
| Sep 21, 2018 | CORAIL AMT HIGH OFFSET NECK SEGMENT (KHO), Pro. Code L20433 Product Usage:... | There is the potential for debris/material to be found behind the O-rings in ... | Class II |
| Sep 21, 2018 | CORAIL AMT COXA VARA NECK SEGMENT (KLA) Pro. Code L20432 Product Usage: T... | There is the potential for debris/material to be found behind the O-rings in ... | Class II |
| Sep 21, 2018 | CORAIL AMT STANDARD OFFSET NECK SEGMENT (STD), Pro. Code L20431 Product Us... | There is the potential for debris/material to be found behind the O-rings in ... | Class II |
| Jul 18, 2018 | P.F.C. SIGMA Revision Knee System Distal Augment, Model Number 960830 | This unit may be missing the screw/collet Assembly | Class II |
| Jun 21, 2018 | CORAIL Cementless Femoral Stem HA Coated Standard Size 11, Catalog No. 3L92511 | Two lots of femoral stems were labeled as Size 11. However, they are actually... | Class II |
| Apr 16, 2018 | ATTUNE Revision CRS Femoral LT SZ 5 Cemented, Catalog No. 150440105, Femoral ... | There may be burrs on the extraction hole threads. | Class II |
| Apr 16, 2018 | ATTUNE Revision CRS Femoral RT SZ 5 Cemented, Catalog No. 150440205, Femoral ... | There may be burrs on the extraction hole threads. | Class II |
| Dec 21, 2017 | (1) Sigma HP Cemented Trochlea Size 1 Narrow Left, Catalog Number: 102403100,... | The SIGMA¿ HP PFJ Cemented Trochlear Implants, a standalone component of the ... | Class II |
| Nov 28, 2017 | The GLOBAL UNITE Platform Shoulder System is intended for cemented or uncemen... | The screw in specific lots of the GLOBAL UNITE Anatomic Body and GLOBAL UNITE... | Class II |
| Aug 31, 2017 | DELTA XTEND" Reverse Shoulder System Modular Centered and Eccentric Epiphysis... | The affected lots are being recalled because the epiphysis may not assemble t... | Class II |
| Aug 31, 2017 | DELTA XTEND" Reverse Shoulder System Modular Centered and Eccentric Epiphysis... | The affected lots are being recalled because the epiphysis may not assemble t... | Class II |
| Jul 26, 2017 | Concorde Lift Driver Shaft AO. Used with supplemental internal spinal fixa... | Potential for Intra-operative breakage of driver tips | Class II |
| Jul 26, 2017 | Concorde Lift Torque Limiting Handle. Must be used with supplemental int... | Potential for Intra-operative breakage of driver tips | Class II |
| Jul 12, 2017 | CORAIL COXA VARA HIGH OFFSET STEM Collared Size 9 | Incorrect device in the package. A package that was labeled as the CORAIL COX... | Class II |
| Jul 12, 2017 | CORAIL HIGH OFFSET STEM Collarless SIZE 14 | Incorrect device in the package. A package that was labeled as the CORAIL COX... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.
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