Synthes (USA) Products LLC

Complete recall history across all FDA and CPSC categories — 162 total recalls

Synthes (USA) Products LLC 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 (162)

FDA medical device enforcement actions by Synthes (USA) Products LLC. Showing most recent 50.

Date Product Reason Class
Sep 26, 2025 LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 42MM / XL25/ STER. Product Code: 0... Although the etched length on the screw is correct, the length marked on the ... Class II
Sep 26, 2025 LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 46MM / XL25/ STER. Product Code: 0... Although the etched length on the screw is correct, the length marked on the ... Class II
Apr 25, 2024 STARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/HXC-Intended for tightening, l... Stardrive Screwdrivers manufactured without a 5-degree relief cut around the ... Class II
Jan 24, 2024 TFNA Femoral Nail 11mm, right, 130¿, L 235mm-Intended for temporary fixation... Products not sterilized, sterility cannot be confirmed Class II
Jan 24, 2024 RIA Tube Assembly, minimum 520 mm length, sterile- intended for use in adult... Products not sterilized, sterility cannot be confirmed Class II
Jan 24, 2024 2.5MM DRILL BIT/QC/GOLD/110MM STERILE-surgical, orthopedic, pneumatic powered... Products not sterilized, sterility cannot be confirmed Class II
Jan 24, 2024 VA-LCP Clavicle Plate 2.7, shaft, CS1, right-Intended for fixation of clavicl... Products not sterilized, sterility cannot be confirmed Class II
Jan 24, 2024 1.5MM Drill Bit/QC/85MM Sterile-surgical, orthopedic, pneumatic powered & acc... Products not sterilized, sterility cannot be confirmed Class II
Jan 24, 2024 TFNA Femoral Nail 9mm, right, 130¿, L 235mm-Intended for temporary fixation ... Products not sterilized, sterility cannot be confirmed Class II
Jan 24, 2024 13 mm Titanium Hindfoot Arthrodesis Cannulated Nails EX, sterile -Intended to... Products not sterilized, sterility cannot be confirmed Class II
Jan 24, 2024 RAPIDSORB IPS Battery Pack, Sterile-Intended for use in non-load bearing frac... Products not sterilized, sterility cannot be confirmed Class II
Jan 24, 2024 Opal, Intervertebral Cage, 10x32mm, h 11mm, Revolvable-Indicated for degenera... Products not sterilized, sterility cannot be confirmed Class II
Feb 1, 2023 TFN-Advanced Femoral Nail 12MM/130 DEG TI CANN TFNA 170MM STERILE. Intende... TFNA Femoral Nails labeled and etched as 200mm may measure 170mm in length, a... Class II
Feb 1, 2023 TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 170MM - STERILE. Intende... TFNA Femoral Nails labeled and etched as 200mm may measure 170mm in length, a... Class II
Feb 1, 2023 TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 200MM STERILE. Intende... TFNA Femoral Nails labeled and etched as 200mm may measure 170mm in length, a... Class II
Sep 27, 2022 SPEED 15X12X12mm Continuous Compression Implant, Product No. SE-1512 The subject products are being recalled because they contain the incorrect si... Class II
Sep 27, 2022 SPEEDSHIFT20x20x20 Offset 10mm Implant Drill Kit, Product No. SE-2020-10. Us... The subject products are being recalled because they contain the incorrect si... Class II
Sep 27, 2022 DePuy Synthes Hammertoe Continuous Compression Implants, Product No. 46.239.001 The subject products are being recalled because they contain the incorrect si... Class II
Sep 27, 2022 SPEED 9X10X10mm Continuous Compression Implant, Product No. SE-0910 The subject products are being recalled because they contain the incorrect si... Class II
Aug 30, 2022 Hammertoe Continuous Compression Implant (CCI) Kit Part Number: 46.239.001 Drill Pin (drill bit) is not compatible with the Drill Template included in t... Class II
Apr 7, 2022 Radial Head Replacement System Implant is a one-piece, stemmed radial head re... DePuy Synthes Radial Head Replacement System Contraindications added to Elect... Class II
Dec 22, 2021 Universal Chuck-The Universal Chuck is an Instrument Handle provided as an al... Top cap may loosen and detach if the Universal Chuck becomes jammed and the u... Class II
Nov 19, 2020 DePuy Synthes 14.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical... RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in ... Class II
Nov 19, 2020 DePuy Synthes 18.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical... RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in ... Class II
Nov 19, 2020 DePuy Synthes 17.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical... RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in ... Class II
Nov 19, 2020 DePuy Synthes 17.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical... RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in ... Class II
Nov 19, 2020 DePuy Synthes 15.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical... RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in ... Class II
Nov 19, 2020 DePuy Synthes 13.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgi... RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in ... Class II
Nov 19, 2020 DePuy Synthes 10.0MM REAMER HEAD FOR RIA 2, STERILE-Orthopedic manual surgic... RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in ... Class II
Nov 19, 2020 DePuy Synthes 10.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical... RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in ... Class II
Nov 19, 2020 DePuy Synthes 11.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical... RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in ... Class II
Nov 19, 2020 DePuy Synthes 14.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgica... RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in ... Class II
Nov 19, 2020 DePuy Synthes 12.5MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgica... RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in ... Class II
Nov 19, 2020 DePuy Synthes 16.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical... RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in ... Class II
Nov 19, 2020 DePuy Synthes 16.0MM REAMER HEAD FOR RIA 2 STERILE--Orthopedic manual surgica... RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in ... Class II
Nov 19, 2020 DePuy Synthes 13.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical... RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in ... Class II
Nov 19, 2020 DePuy Synthes 15.0MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgica... RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in ... Class II
Nov 19, 2020 DePuy Synthes 11.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical... RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in ... Class II
Nov 19, 2020 DePuy Synthes 12.0MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgica... RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in ... Class II
Sep 21, 2020 DePuy Synthes SYNMESH 10MM DIA 18MM HEIGHT (TI) Product Number: 495.344 - Pr... Incorrectly Labeled 'general medical device,' printed on the statutory labe... Class III
Sep 21, 2020 STANDARD RING 22MM X 28MM (TI) Product Number: 495-406 - Product Usage: is a... Incorrectly Labeled 'general medical device,' printed on the statutory labe... Class III
Sep 21, 2020 END RING 22MM X 28MM LATERAL OR ANTERIOR/0 DEG (TI) Product Number: 495-396 ... Incorrectly Labeled 'general medical device,' printed on the statutory labe... Class III
Sep 21, 2020 END RING 17MM X 22MM LATERAL OR ANTERIOR/0 DEG (TI) Product Number: 495.392 ... Incorrectly Labeled 'general medical device,' printed on the statutory labe... Class III
Sep 21, 2020 END RING 12MM DIA/0 DEG (TI) Product Number: 495.385 - Product Usage: is a v... Incorrectly Labeled 'general medical device,' printed on the statutory labe... Class III
Sep 21, 2020 SYNMESH 17MM X 22MM 88MM HEIGHT (TI) Product Number: 495-374 - Product Usag... Incorrectly Labeled 'general medical device,' printed on the statutory labe... Class III
Sep 21, 2020 END RING 10MM DIA/0 DEG (TI) Product Number: 495.384 - Product Usage: is a v... Incorrectly Labeled 'general medical device,' printed on the statutory labe... Class III
Sep 21, 2020 SYNMESH 15MM DIA 88MM HEIGHT (TI) Product Number: 495.366 - Product Usage: ... Incorrectly Labeled 'general medical device,' printed on the statutory labe... Class III
Sep 21, 2020 SYNMESH 12MM DIA 88MM HEIGHT (TI) Product Number: 495.357 - Product Usage: ... Incorrectly Labeled 'general medical device,' printed on the statutory labe... Class III
Sep 21, 2020 3.0MM LOCKING SCREW LOW PROFILE (TI) Product Number: 495-491 - Product Usag... Incorrectly Labeled 'general medical device,' printed on the statutory labe... Class III
Sep 21, 2020 END RING 15MM DIA/0 DEG (TI) Product Number: 495.386 - Product Usage: is a v... Incorrectly Labeled 'general medical device,' printed on the statutory labe... Class III

View all 162 device recalls →

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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