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.
What this means for you
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.
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- High