Browse Device Recalls

56 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 56 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 56 FDA device recalls.

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Date	Product	Reason	Class	Firm
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 Material Mix were mix...	Class II	Synthes USA HQ, Inc.
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 J5606-C "TomoFix Oste...	Class II	Synthes USA HQ, Inc.
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 breaking at the interface b...	Class II	Synthes USA HQ, Inc.
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 allow for unretrieved...	Class II	Synthes USA HQ, Inc.
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 to be mislabeled as S...	Class II	Synthes USA HQ, Inc.
Oct 3, 2013	Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical Blade Synthes Ti...	A potential exists for non conforming Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical B...	Class II	Synthes USA HQ, Inc.
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 screw could back ou...	Class II	Synthes USA HQ, Inc.
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 Retractor if it is ove...	Class II	Synthes USA HQ, Inc.
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 to cut the implant wh...	Class II	Synthes USA HQ, Inc.
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 (clamping sleeve) malf...	Class II	Synthes USA HQ, Inc.
Jul 31, 2013	Synthes Matrix Threaded Persuader Deformity is a comprehensive thoracolumb...	Synthes became aware that during a procedure using the Matrix Threaded Persuader, the Reduction I...	Class II	Synthes USA HQ, Inc.
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 to a mislabeling issu...	Class II	Synthes USA HQ, Inc.
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 Epiphysis System to sti...	Class II	Synthes USA HQ, Inc.
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 because of complaints ...	Class II	Synthes USA HQ, Inc.
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 for the reaction for...	Class II	Synthes USA HQ, Inc.
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 Condylar Plate is et...	Class II	Synthes USA HQ, Inc.
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 the incorrect label...	Class II	Synthes USA HQ, Inc.
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 a specific lot are e...	Class II	Synthes USA HQ, Inc.
Jul 30, 2013	Synthes Titanium Cannulated Humeral Nail Intended to aid in the alignment...	The packaging incorrectly depicts the Synthes Titanium Cannulated Humeral Nail as a 3 distal hole...	Class II	Synthes USA HQ, Inc.
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 second bend in the n...	Class II	Synthes USA HQ, Inc.
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 the packaging of the...	Class II	Synthes USA HQ, Inc.
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 complaints of break...	Class II	Synthes USA HQ, Inc.
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 Coronal Bender breaking ...	Class II	Synthes USA HQ, Inc.
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 of the Craniomaxill...	Class II	Synthes USA HQ, Inc.
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 and the potential fo...	Class II	Synthes USA HQ, Inc.
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 Stainless Steel rods. T...	Class II	Synthes USA HQ, Inc.
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 numbers and lot numbe...	Class II	Synthes USA HQ, Inc.
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 for sale.	Class II	Synthes USA HQ, Inc.
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 Nail recall had been d...	Class II	Synthes USA HQ, Inc.
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 Electric Pen Drive ...	Class II	Synthes USA HQ, Inc.
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 additional clarificat...	Class II	Synthes USA HQ, Inc.
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 241.267 was mislabeled wi...	Class II	Synthes USA HQ, Inc.
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 the arm during surgery...	Class II	Synthes USA HQ, Inc.
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), was released to th...	Class II	Synthes USA HQ, Inc.
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 was reported that the ...	Class II	Synthes USA HQ, Inc.
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 and the 11 mm socket...	Class II	Synthes USA HQ, Inc.
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 Titanium Midface Distracto...	Class II	Synthes USA HQ, Inc.
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 be made according to ...	Class II	Synthes USA HQ, Inc.
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 355.28) which is part ...	Class II	Synthes USA HQ, Inc.
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 be made according to ...	Class II	Synthes USA HQ, Inc.
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 incorrectly etched as Pa...	Class II	Synthes USA HQ, Inc.
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 be made according to ...	Class II	Synthes USA HQ, Inc.
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), was incorrectly et...	Class II	Synthes USA HQ, Inc.
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 fixation of the Den...	Class II	Synthes USA HQ, Inc.
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 compromised. The product is...	Class II	Synthes USA HQ, Inc.
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 incorrectly, 12mm etch i...	Class II	Synthes USA HQ, Inc.
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 provided with the Tu...	Class II	Synthes USA HQ, Inc.
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 that this product is M...	Class II	Synthes USA HQ, Inc.
Sep 7, 2012	Synthes Titanium Minimally Invasive Reduction Screw System Locking Cap, Part ...	This action is being initiated following a detailed investigation in response to reported complai...	Class II	Synthes USA HQ, Inc.
Sep 7, 2012	Synthes Titanium Minimally Invasive Reduction Screw System Polyaxial Screw Bo...	This action is being initiated following a detailed investigation in response to reported complai...	Class II	Synthes USA HQ, Inc.

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.