Synthes (USA) Products LLC: 38 recalls on record

Recalls filed with 1 agency: FDA (38).

First recall on record: August 1, 2012. Most recent: June 5, 2024.

Risk classification: Class I: 1 · Class II: 35 · Class III: 2

Most recent recalls

DateAgencyProduct
June 5, 2024FDASTARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/HXC-Intended for tightening, loosening, or…Z-1916-2024
March 13, 2024FDAOpal, Intervertebral Cage, 10x32mm, h 11mm, Revolvable-Indicated for degenerative spine d…Z-1242-2024
March 13, 2024FDARAPIDSORB IPS Battery Pack, Sterile-Intended for use in non-load bearing fracture repair …Z-1238-2024
March 13, 2024FDA13 mm Titanium Hindfoot Arthrodesis Cannulated Nails EX, sterile -Intended to facilitate …Z-1234-2024
March 13, 2024FDATFNA Femoral Nail 9mm, right, 130¿, L 235mm-Intended for temporary fixation and stabiliz…Z-1239-2024
March 13, 2024FDATFNA Femoral Nail 11mm, right, 130¿, L 235mm-Intended for temporary fixation and stabili…Z-1240-2024
March 13, 2024FDA2.5MM DRILL BIT/QC/GOLD/110MM STERILE-surgical, orthopedic, pneumatic powered & accessory…Z-1236-2024
March 13, 2024FDARIA Tube Assembly, minimum 520 mm length, sterile- intended for use in adults and adoles…Z-1237-2024
March 13, 2024FDAVA-LCP Clavicle Plate 2.7, shaft, CS1, right-Intended for fixation of clavicle bone fragm…Z-1241-2024
March 13, 2024FDA1.5MM Drill Bit/QC/85MM Sterile-surgical, orthopedic, pneumatic powered & accessory/attac…Z-1235-2024
May 18, 2022FDARadial Head Replacement System Implant is a one-piece, stemmed radial head replacement. T…Z-1072-2022
February 16, 2022FDAUniversal Chuck-The Universal Chuck is an Instrument Handle provided as an alternative in…Z-0634-2022
December 23, 2020FDADePuy Synthes 12.0MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgical instrument…Z-0575-2021
December 23, 2020FDADePuy Synthes 11.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument …Z-0574-2021
November 11, 2020FDAEND RING 17MM X 22MM LATERAL OR ANTERIOR/5 DEG (TI) Product Number: 495.394 - Product U…Z-0412-2021
November 11, 2020FDAEND RING 22MM X 28MM LATERAL OR ANTERIOR/5 DEG (TI) Product Number: 495-398 - Product U…Z-0414-2021
October 31, 2018FDA3.0mm Headless Compression Screw, Long Thread 18mm, Part Number 04.226.118 DePuy Synt…Z-0238-2019
June 27, 2018FDAPart no. 690.379, Graphic Case F/6.5mm Cannulated Screw SetZ-2246-2018
May 16, 2018FDARetractor f/Sciatic Nerve; Part number: 03.100.013; UDI: 10886982070623Z-1758-2018
March 8, 2017FDAPRODISC Orthopedic Manual Surgical Instrument, strut used in spinal surgery. Part numbe…Z-1383-2017
November 30, 2016FDAExtraction Hook - Sterile for TI Cannulated NailsZ-0642-2017
November 30, 2016FDA3.0 mm Guide Rod/950 mm with Smooth Tip, sterileZ-0640-2017
November 30, 2016FDA2.5 mm Guide Rod w/Smooth Tip 950 mm, SterileZ-0641-2017
July 20, 2016FDA6.5 mm Cannulated Screw, Product code HWC, Device Listing Number D028949, Screw, Fixation…Z-2152-2016
July 20, 2016FDA4.5 mm Cannulated Screw, Product code HWC, Device Listing Number D029092 and D120718, Scr…Z-2157-2016

Questions about this company

How many recalls does Synthes (USA) Products LLC have?
Recalert has 38 U.S. recalls on record for Synthes (USA) Products LLC, published between August 1, 2012 and June 5, 2024.
What was the most recent Synthes (USA) Products LLC recall?
FDA recall Z-1916-2024, published June 5, 2024: 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
Which agencies have handled Synthes (USA) Products LLC recalls?
Synthes (USA) Products LLC appears as the recalling firm in recalls from: FDA (38).

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