Synthes Implant Holder Recalled Due to Breakage During Orthopedic Surgery
Synthes USA HQ, Inc. is recalling 548 Synfix (TM)-LR Implant Holders because they may break at the interface between the implant and the holder.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a structural defect (breakage) that poses a risk of harm during surgery, but the source text does not report specific injuries or fatalities, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Synthes USA HQ, Inc. is recalling 548 units of the Synthes Implant Holder for Synfix (TM)-LR. This non-powered hand-held device is intended for medical purposes to manipulate tissue or for use with other devices in orthopedic surgery.
The recall was initiated after complaints were received describing the device breaking at the interface between the implant and the holder. The recall covers all lots of part no. 03.802.039.
The affected units were distributed nationwide in the United States and internationally to Canada. Healthcare providers should stop using the recalled devices and contact the manufacturer for further instructions.
The recalled product
- Product
- Synthes Implant Holder for Synfix (TM)-LR the Synthes Implant Holder for Synfix (TM)-LR is a non-powered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery
- Manufacturer
- Synthes USA HQ, Inc.
- Hazard
- Affected units
- 548
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- all lots of part no. 03.802.039
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Synthes USA HQ, Inc.
See all →- ModerateSynthes Electric Pen Drive Hand Switch Recalled for Labeling Error
FDA (Devices) · 2014-01-08
- ModerateSynthes TomoFix Osteotomy System Recalled for Surgical Technique Guide Labeling Error
FDA (Devices) · 2013-12-18
- ModerateSynthes Trochanteric Fixation Nail Recalled for Incorrect Packaging Labeling
FDA (Devices) · 2013-12-18
- SevereSynthes Recalls Titanium Trochanteric Fixation Nail Systems Due to Missing Bend
FDA (Devices) · 2013-12-11
- ModerateSynthes Soft Tissue Retractor Recalled for Locking Nut Malfunction
FDA (Devices) · 2013-12-11
Same hazard · structural failure
See all →- High
- ModerateQuantum Ops Recalls ADAPTABLE Beach Chair Surgical Patient Positioners
FDA (Devices) · 2026-10-14
- SevereMedline Bariatric Rollator Recalled Due to Front Wheel Assembly Disconnect Risk
FDA (Devices) · 2026-10-14
- SevereMedline Bariatric Rollator Recalled Due to Front Wheel Detachment Risk
FDA (Devices) · 2026-10-14
- SeverePacearth Recalls Swing Seats Due to Serious Injury Risk from Falling
CPSC · 2026-10-08
Similar recalls
- SevereSynthes 8.5 MM Medullary Reamer Recalled Due to Intraoperative Breakage
FDA (Devices) · 2013-11-20
- ModerateSynthes Threaded Plate Holder Recalled for Incorrect Part Number Etching
FDA (Devices) · 2015-11-04
- SevereSynthes Sternal Zip Flex System Recalled for Implant Cutting Risk
FDA (Devices) · 2013-11-06
- HighSynthes Tensioning Device Recalled Due to Potential Mechanical Failure
FDA (Devices) · 2013-12-04
- SevereSynthes Recalls Titanium Elastic Nail Inserters Due to Mechanical Failure Risk
FDA (Devices) · 2015-10-21
- HighSynthes Recalls 8.5mm Reamer Heads for Potential Intraoperative Breakage
FDA (Devices) · 2015-08-19