Biomet Microfixation RapidFlap System 16MM RapidFlap SpinDown Clamp… — Class II medical device recall Z-0395-2019
Terminated recall by Zimmer Biomet, Inc., reported 2018-11-14, distributed nationwide. Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly.
| Recall number | Z-0395-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2018-08-22 |
| Classified | 2018-11-06 |
| Reported by FDA | 2018-11-14 |
| Terminated | 2021-06-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AU, BE, BR, CA, CH, CL, CN, CO, CR, CZ, DE, DO, EC, ES, FI, FR, GB, GR, HK, ID, IT, JO, JP, KR, LB, MY, PE, PY, SE, SG, TH, TR, TT, UY, VN, ZA |
| Quantity | 23,726 units |
| Model numbers | 75-1030 |
Product
Biomet Microfixation RapidFlap System 16MM RapidFlap SpinDown Clamp Ref Number: 75-1030 Used for the re-attachment of the bone flap after a craniotomy.
Reason for recall
Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly.
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-0395-2019. 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.