Device product
SPEED 15X12X12mm Continuous Compression Implant, Product No. SE-1512
Z-0099-2023
Product summary
- Event
- Event 90918
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 94 US; 30 OUS
- Official record key
device-enforcement:Z-0099-2023
Official wording
Reason: The subject products are being recalled because they contain the incorrect size drill guide and will not prepare the bone correctly for the size of the implant included in the sterile kit. If the incorrect drill guide is used, there is potential for bone damage due to incorrectly placed drill holes for the implant included in the kit.
Code information: UDI-DI (GTIN): 00810633020166 Lot/Expiry MSE220445 7/1/2027 MSE210184 8/1/2026
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
The subject products are being recalled because they contain the incorrect size drill guide and will not prepare the bone correctly for the size of the implant included in the sterile kit. If the incorrect drill guide is used, there is potential for bone damage due to incorrectly placed drill holes for the implant included in the kit.