Palacos¿ R+G Radioplaque Bone Cement 1 x 40 g Single — Class II medical device recall Z-0730-2014
Terminated recall by Zimmer, Inc., reported 2014-01-22, distributed nationwide. The patient label associated with the product may be incorrect in that the lot number on the patient label may
| Recall number | Z-0730-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer, Inc., Warsaw, IN, United States |
| Recall initiated | 2013-11-04 |
| Classified | 2014-01-13 |
| Reported by FDA | 2014-01-22 |
| Terminated | 2014-10-08 |
| Distributed | Nationwide (US) |
| Quantity | 1,534 units |
| Reason classes | labeling |
| Lot numbers | 75974340 |
| Model numbers | 00-1113-140-01 |
Product
Palacos¿ R+G Radioplaque Bone Cement 1 x 40 g Single (with Gentamicin), 40.8 g Methyl Acrylate Copolymer, 20 ml Methyl Methacrylate Monomer 0.5 g Gentamicin, Distributed by Zimmer Dover, OH 44522 The cement is indicated for use in the second stage of a two stage revision for total joint arthroplasty after the initial infection has been cleared.
Reason for recall
The patient label associated with the product may be incorrect in that the lot number on the patient label may be different than the lot number on the outer carton label.
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-0730-2014. 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.