Surgical Implant Kit Recall: Incorrect Drill Guide Included
Synthes surgical implant kits are being recalled because they contain an incorrect size drill guide that cannot properly prepare the bone for the implant, creating a risk of bone damage during surgery.
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 is an FDA Class II medical device recall involving a functional defect (incorrect drill guide) that creates direct risk of bone damage during surgical implantation. No illnesses or injuries have been reported to date, placing it in the 'High' category as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Synthes (USA) Products LLC is recalling SPEED 15X12X12mm Continuous Compression Implant kits (Product No. SE-1512) distributed nationwide in the United States.
The kits contain an incorrect size drill guide. When used during surgical implantation, the incorrect drill guide will not properly prepare the bone for the implant size included in the kit. This creates a risk of bone damage due to incorrectly placed drill holes.
The affected lot numbers are MSE220445 (expiring 7/1/2027) and MSE210184 (expiring 8/1/2026). The recall impacts 94 units distributed in the United States and 30 units distributed outside the United States.
The recalled product
- Product
- SPEED 15X12X12mm Continuous Compression Implant, Product No. SE-1512
- Manufacturer
- Synthes (USA) Products LLC
- Hazard
- bone-damage
- surgical-defect
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)
- UDI-DI (GTIN): 00810633020166 Lot/Expiry MSE220445 7/1/2027 MSE210184 8/1/2026
Distribution
Distributed nationwide across the United States.
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