Zimmer Recalls Palacos R+G Bone Cement Due to Labeling Error
Zimmer, Inc. is recalling 1,534 units of Palacos R+G Radioplaque Bone Cement because the lot number on the patient label may not match the outer carton.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text identifies the issue as a labeling discrepancy (lot number mismatch) without reporting any illnesses or injuries, fitting the criteria for a moderate severity labeling error.
Plain-English summary
Zimmer, Inc. is recalling 1,534 units of Palacos R+G Radioplaque Bone Cement 1 x 40 g Single (with Gentamicin). The product is indicated for use in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared.
The recall was initiated because the patient label associated with the product may be incorrect. Specifically, the lot number on the patient label may be different than the lot number on the outer carton label. The affected product is identified by Cat No. 00-1113-140-01 and lot 75974340.
The product was distributed nationwide, including in Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maine, Michigan, Minnesota, Missouri, North Carolina, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia, and Wyoming. Healthcare providers should verify the lot numbers on the patient labels and outer cartons to ensure they match.
The recalled product
- 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…
- Manufacturer
- Zimmer, Inc.
- Hazard
- Affected units
- 1,534
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Cat No. 00-1113-140-01
- lot 75974340
Distribution
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