Zimmer Versys Cemented Femoral Stem Recall for Calibration Issues
Zimmer Manufacturing B.V. is recalling 13 Versys Cemented Femoral Stems due to insufficient sealer calibration data. The affected sterile products were distributed nationwide in the US.
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, which is typically associated with a temporary or medically reversible adverse health consequence. The source text does not report any injuries, illnesses, or deaths, and the hazard is related to manufacturing calibration data rather than a confirmed structural failure or contamination.
Plain-English summary
Zimmer Manufacturing B.V. is recalling 13 units of Versys Cemented Femoral Stems (Item nos. 785301701, 785301521, and 785301601) used for total or hemi hip arthroplasty. The recall is being conducted because of insufficient sealer calibration data for products packaged in the firm's Building II between August 2010 and April 2013.
The affected products are sterile and were distributed nationwide in the United States. Specific lot numbers associated with this recall include 370967, 00370967N, 62279438, 62012576, and 62012576N.
Healthcare providers and patients should check their inventory and records for these specific item numbers and lot codes. If the product is identified, it should be removed from use and returned to the manufacturer or an authorized representative in accordance with the recall instructions.
The recalled product
- Product
- Product 69 consists of all product under product code: JDI and same usage: Item no: 785301701 VERSYS CEMENTED FEM STEM 785301521 VERSYS CEMENTED FEM STEM 15X140MM X-OFF 785301601 VERSYS CEMENTED FEM STEM 16X145MM For use in total or hemi hip arthroplasty
- Manufacturer
- Zimmer Manufacturing B.V.
- Affected units
- 13
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 (1)
- lot no.: 370967 00370967N 62279438 62012576 62012576N
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 72 recalled by Zimmer Manufacturing B.V. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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