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
July 20, 2016FDA4.5 mm Cortex Screw, Product code HWC, Device Listing Number D137402, Screw, Fixation Bon…Z-2156-2016
July 20, 2016FDAPart # 313.250, 1.1mm Drill Bit, Mini QC with 4mm Stop/44.5mm, lot # 4326989, mfg. 9/28/2…Z-2199-2016
July 20, 2016FDAPart # 313.232, 2.0mm Stardrive Screwdriver Bld Slf-Retain Med/66mm MQC, lot # 4363820, …Z-2198-2016
June 1, 2016FDA3.2 mm Three-fluted drill bit, sterile, Catalog ID # 03.010.060S Product Usage: Usage…Z-1709-2016
April 20, 2016FDASYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Subst…Z-1385-2016
December 2, 2015FDA2.4MM locking screw SLF-TPNG with Stardrive Recess 18 mm. Intended for fixation of fract…Z-0323-2016
September 2, 2015FDASynthes Trauma Ex-Fix System (Small, Medium, Distraction Osteogenesis (DO) and Large) ; (…Z-2451-2015
September 2, 2015FDASynthes Application Instrument for Sternal ZIPFIX; indications for use include primary or…Z-2475-2015
December 3, 2014FDASynthes Titanium Polyaxial Reduction Head for Titanium Matrix Spine Screws: The Titanium …Z-0226-2015
December 4, 2013FDASynthes 14.5 mm Outer Protection Sleeve for Suprapatellar Synthes 14.5 mm Outer Prote…Z-0404-2014
December 4, 2013FDASynthes 2.4 mm LC-DCP Plate 6 Holes/51mm Product Usage: Intended for fractures, osteo…Z-0406-2014
September 4, 2013FDASynthes 2.4mm VA-LCP Two Column Volar Distal Radius Plate and Torque limiting attachment,…Z-2057-2013
August 1, 2012FDAUniversal Spinal System Lamina Hooks Synthes Medium TI Lamina Hook - Right 498.320 No…Z-2054-2012

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.
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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