Osteobond Bone Cement Bone cement monomer is kitted with bone cement… — Class II medical device recall Z-0900-2015
Terminated recall by Zimmer, Inc., reported 2015-01-07, distributed in CA, KS, MI. Samples of product from Supplier lot 14D0809 and 14D0808 showed little adhesive transfer between the Tyvek lid
| Recall number | Z-0900-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer, Inc., Warsaw, IN, United States |
| Recall initiated | 2014-12-08 |
| Classified | 2014-12-31 |
| Reported by FDA | 2015-01-07 |
| Terminated | 2015-07-17 |
| Distributed | CA, KS, MI |
| Quantity | 40 units |
| Lot numbers | 14D0809, 62849791 |
| Model numbers | 00-1101-012-00 |
| Expiration dates | 2017-04-30 |
Product
Osteobond Bone Cement Bone cement monomer is kitted with bone cement powder to create a cement mantle for orthopedic implants.
Reason for recall
Samples of product from Supplier lot 14D0809 and 14D0808 showed little adhesive transfer between the Tyvek lid and cavity when opened for internal bone cement cure and pairing tests. Visually these samples do not meet the requirements of ZWI 43.109 and corresponding visual aid 55-0000-310-01.
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-0900-2015. 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.