Synthes USA HQ, Inc.

Complete recall history across all FDA and CPSC categories — 56 total recalls

Synthes USA HQ, 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 (56)

FDA medical device enforcement actions by Synthes USA HQ, Inc.. Showing most recent 50.

Date Product Reason Class
Oct 15, 2013 Synthes Material Mix (Adjustable Cervical Distractor-Right, Matrix Distractor... One material batch used for production of the affected parts of the Synthes M... Class II
Oct 9, 2013 Synthes TomoFix Plates The Synthes J5606-C TomoFix Osteotomy System is use... A labeling correction was initiated related to the Surgical Technique Guide J... Class II
Oct 8, 2013 Synthes Implant Holder for Synfix (TM)-LR the Synthes Implant Holder for S... Complaints were received which described the SynFix LR implant holder breakin... Class II
Oct 3, 2013 Synthes 8.5 MM Medullary Reamer Product Usage: An orthopedic manual surg... Complaints were received for intraoperative reamer head breakages which can a... Class II
Oct 3, 2013 Synthes Spiked Washers 13.5/6.5 Spiked Washers 13.5/6.5 are intended to be... During a retrospective assessment, Spiked Washers 13.5/6.5 were discovered t... Class II
Oct 3, 2013 Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical Blade Synthes Ti... A potential exists for non conforming Synthes Titanium Trochanteric Fixation ... Class II
Sep 30, 2013 Synthes Zero-P VA Implant 7 MM Height Parallel Sterile The Synthes Zero-P ... A potential non conformance was identified with the Zero-P VA plate where the... Class II
Sep 24, 2013 Synthes Soft Tissue Retractor Small Extendible Offset blade facilitates ea... The potential exists for the locking screw nut to break on the Soft Tissue Re... Class II
Aug 13, 2013 Synthes Application Instrument Sternal Zip Flex System intended for use in... When using the 1st generation Zip Fix Application Instrument it is possible t... Class II
Aug 1, 2013 Synthes Soft Tissue Retractor Small Extendible. Offset blade facilitates e... The small extendible Soft Tissue Retractor was recalled due to locking nut (c... Class II
Jul 31, 2013 Synthes Matrix Threaded Persuader Deformity is a comprehensive thoracolumb... Synthes became aware that during a procedure using the Matrix Threaded Persua... Class II
Jul 31, 2013 2.4 and 2.7 MM Locking Screw SLF-TPNG with T8 Stardrive Recess 12 MM Fixatio... Specific lots of the SS 2.4mm and SS 2.7mm Locking Screw (self-tapping) due t... Class II
Jul 31, 2013 Slipped Capital Femoral Epiphysis System Product Usage: Intended for fra... There is a possibility for the Guide Wires of the Slipped Capital Femoral Epi... Class II
Jul 31, 2013 Large Buttress Compression Nut For Blade Guide Sleeve TFN The Synthes Lar... The Large Buttress Compression Nut For Blade Guide Sleeve TFN was recalled be... Class II
Jul 31, 2013 Synthes Tensioning Device The Synthes Osteogenesis System, MR Conditional... All lots of the Synthes Tensioning Device were recalled due to the potential ... Class II
Jul 30, 2013 Synthes 4.5 mm LCP Curved Condylar Plate Intended for buttressing multifr... The Synthes 4.5 mm LCP Curved Condylar Plate was recalled because a Straight ... Class II
Jul 30, 2013 Synthes Trochanteric Fixation Nail As part of the Synthes Trochanteric Fi... Certain lots of Trochanteric Fixation Nail were distributed to the field with... Class II
Jul 30, 2013 Synthes 2.4 VA-LCP 2 CLMN VLR DSTL Radius PL 7H HD/3H Shaft/Right Product ... The possibility exists that 2.4 mm VA-LCP 2 column distal radius plates from ... Class II
Jul 30, 2013 Synthes Titanium Cannulated Humeral Nail Intended to aid in the alignment... The packaging incorrectly depicts the Synthes Titanium Cannulated Humeral Nai... Class II
Jul 30, 2013 Titanium Trochanteric Fixation Nail (TFN)System Intended to treat stable a... Two lots of Titanium Trochanteric Fixation Nail (TFN) System are missing the ... Class II
Jul 30, 2013 Vertebroplasty Needle Kit 10g Diamond Tip Intended to be used to inject P... Complaints were received of inconsistencies in the expiration dates shown on ... Class II
Jul 22, 2013 3.7mm and 5.0mm Dynamic Locking Screw (DLS) Product Usage: 3.7mm and 5.... All lots of 3.7mm and 5.0mm Dynamic Locking Screw (DLS) were recalled due to... Class II
Jun 22, 2013 Synthes Matrix 5.5.mm Left and Right Coronal Bender Product Usage: The M... A complaint was received of the tips of the Matrix 5.5.mm Left and Right Coro... Class II
Jun 12, 2013 Synthes CMF Distraction System The product is intended for use as a bone s... The firm initiated a voluntary recall of the BC Distractor Body which is part... Class II
Jun 11, 2013 Synthes Flexible Medullary Reamer. Intended to be used to facilitate the p... Due to the coiled design for this product, the product is difficult to clean ... Class II
Jun 5, 2013 5.0mm Unit Rod 270mm 5.0mm Unit Rod 290mm 5.0mm Unit Rod 310mm 5.0mm Unit ... DePuy Synthes has issued a Medical Device Correction notice for the 5.0mm Sta... Class II
May 31, 2013 Multi Vector Distractor Pin Holding Clamp, limited bone stock The holding ... Synthes is initiating a voluntary Medical Device removal for specified part n... Class II
May 29, 2013 Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER Synthes 4.5MM T... A plate was inadvertently released to a sales consultant that was restricted ... Class II
Apr 18, 2013 Synthes Cannulated Distal Femoral Nail (Trauma Nail), Part Number 450.851S, 4... Firm discovered that a nail that was within the scope of a previous Trauma Na... Class II
Apr 15, 2013 Synthes Hand Switch - Electric Pen Drive, Part Number 05.001.012 The Synth... Synthes received a complaint from a customer in which the Hand Switch for the... Class II
Mar 8, 2013 Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, ... A post market safety review following several customer complaints indicated a... Class II
Mar 8, 2013 Synthes 3.5 MM LCP(R) Distal Humerus System The Synthes 3.5 MM LCP Distal ... Recall is being initiated due to the part being mislabeled (Part Number 241.2... Class II
Feb 22, 2013 Synthes Radial Head Prosthesis: Trial Radial Head Elbow joint prosthesis: ... The Trial Head may come loose from the implant stem during manipulation of th... Class II
Feb 22, 2013 Synthes 11-Hole, 1/3 Tubular Plate DCL Plate with Collar, Part Number 241.000... The Synthes One-Third Tubular DCL Plate (11-Hole, 1/3 Tubular Plate w/Collar)... Class II
Jan 11, 2013 Synthes Oracle Spacer System Slap Hammer, Part Number 03.809.690, Lot Number ... This recall is being initiated in response to complaints received where it wa... Class II
Jan 11, 2013 Large Combination Clamp/Large External Fixation System, Part Number 390.005 ... The L1 hex nuts, used to tighten the Large Combination Clamp, were oversized ... Class II
Jan 11, 2013 Synthes Titanium Midface Distractor, MR Conditional, Part number 487.982. Fo... There is the potential for the anterior footplates to not fit onto the Titani... Class II
Jan 11, 2013 Synthes Multi-Vector Distractor, Multi-axial Mandible Distractor (Right), Par... It was discovered that the sheer pin on the Multi-Vector Distractor may not b... Class II
Jan 11, 2013 Flexible Grip which is part of the Synthes Universal Nail System. Indicate... Synthes is initiating a voluntary recall of the Flexible Grip (Part number 35... Class II
Jan 11, 2013 Synthes Multi-Vector Distractor Body, Part Number 487.931. For mandibular ... It was discovered that the sheer pin on the Multi-Vector Distractor may not b... Class II
Jan 11, 2013 Variable Angle Locking Compression Plate/VA-LCP Dorsal Distal Radius Plate, P... It was discovered that one of the VA-LCP Dorsal Distal Radius Plates was inco... Class II
Jan 11, 2013 Synthes Multi-Vector Distractor - Multi-axial Mandible Distractor (Left), Par... It was discovered that the sheer pin on the Multi-Vector Distractor may not b... Class II
Jan 11, 2013 Synthes Spine 5.2mm Titanium Click ' X Pedicle Screw Dual Core 40 mm Thread L... Lot number 7542279, of the 45 mm Click 'X Pedicle Screw (Part number 487.072)... Class II
Jan 11, 2013 Synthes Dens Instrument Set (Dens Graphic Case), Part Number 687.030 (also kn... The Dens Instrument Set has been designed to facilitate the anterior internal... Class II
Nov 2, 2012 Synthes Trauma Nail System. The devices are indication for bone fixation. Recall was initiated due to the possibility that the outer pouch was compromi... Class II
Oct 12, 2012 Synthes Synapse SD Drill Guide, Part Number SD389.477, Lot Number 6913900 ... A complaint was received from the field, that the drill guide was etched inco... Class II
Oct 12, 2012 Synthes Large External Fixation, MR Conditional, Tube to Tube Clamp, Part Num... It was discovered internally that there was a discrepancy between the insert ... Class II
Sep 28, 2012 Synthes External Fixation System Tube to Tube Clamp, Part Number 390.007. ... The insert provided with the product for the specific lot number indicates th... Class II
Sep 7, 2012 Synthes Titanium Minimally Invasive Reduction Screw System Locking Cap, Part ... This action is being initiated following a detailed investigation in response... Class II
Sep 7, 2012 Synthes Titanium Minimally Invasive Reduction Screw System Polyaxial Screw Bo... This action is being initiated following a detailed investigation in response... Class II

View all 56 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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