LCP Drill Sleeve 1 — Class II medical device recall Z-0669-2018
Terminated recall by Synthes, Inc., reported 2018-02-28. May have difficulty attaching the drill sleeve to the plate. If the drill sleeve will not connect to the plate
| Recall number | Z-0669-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Synthes, Inc., West Chester, PA, United States |
| Recall initiated | 2017-08-07 |
| Classified | 2018-02-21 |
| Reported by FDA | 2018-02-28 |
| Terminated | 2018-07-25 |
| Countries outside the US | CA, DE |
| Quantity | 567 units |
| Lot numbers | 9972971, FT00227, H028400, H161606, H288454 |
| Model numbers | 03.114.001 |
Product
LCP Drill Sleeve 1.5 Drill Bit 1.1mm Part Number 03.114.001 Used in LCP Modular Mini Fragment System, for fixation of small bones and small bone fragments
Reason for recall
May have difficulty attaching the drill sleeve to the plate. If the drill sleeve will not connect to the plate intraoperatively, surgical delay could occur. If the pilot hole is drilled without the drill sleeve, the pilot hole could be off-center which could result in screw and/or plate loosening.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0669-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.