FDA Device recall Z-0099-2023
SPEED 15X12X12mm Continuous Compression Implant, Product No. SE-1512
- FDA Device
- Class II
- ongoing
- Published 2022-10-26
On 2022-10-26 the FDA classified a Class II recall of SPEED 15X12X12mm Continuous Compression Implant, Product No. SE-1512 by Synthes Usa Products, citing 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 ste….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0099-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-09-27 |
| Published | 2022-10-26 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Synthes Usa Products |
| Distribution | US |
Product
SPEED 15X12X12mm Continuous Compression Implant, Product No. SE-1512
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.
Identifiers
| code_info | UDI-DI (GTIN): 00810633020166 Lot/Expiry MSE220445 7/1/2027 MSE210184 8/1/2026 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0099-2023%22
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