Surgical screwdrivers recalled for failure to engage with implant screws
Synthes surgical screwdrivers are being recalled because they lack a required relief cut and will not engage properly with 1.3mm and 1.5mm implant screws, potentially delaying surgery. The defect affects 261 units distributed in the US and Canada.
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: This FDA Class II medical device recall involves a manufacturing defect that prevents proper function with certain implant screws. No reported illnesses or injuries and the hazard is theoretical (surgical delay). Per the scoring rubric, this is classified as High severity because it is a risk-of-harm medical device with no reported injuries.
Plain-English summary
Synthes (USA) Products LLC is recalling STARDRIVE SCRWDRVR SHFT/T4 50MM surgical screwdrivers (Part Number 03.130.010) intended for orthopedic surgery. The screwdrivers were manufactured without a 5-degree relief cut around the tip.
Due to this defect, the screwdrivers will not engage with their respective 1.3mm and 1.5mm implant screws, which may result in surgical delays.
The recall affects 261 units distributed in the US nationwide and in Canada. The affected lot numbers are 97P6250, 97P6251, and 97P6252.
The recalled product
- Product
- STARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/HXC-Intended for tightening, loosening, or removing of screw implants during orthopaedic surgery. Part Number: 03.130.010
- Manufacturer
- Synthes (USA) Products LLC
- Hazard
- surgical-delay
- tool-malfunction
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 (3)
- UDI-DI: 10886982075192 Lot Numbers: 97P6250
- 97P6251
- 97P6252
Distribution
Distributed nationwide across the United States.
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