Zimmer Versys Advocate Hip Implants Recalled for Calibration Issues
Zimmer Manufacturing B.V. is recalling Versys Advocate hip implants due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a potential failure of sterile sealers in a medical device. Per the rubric, risk-of-harm products where injury has not yet been reported are rated as High (3).
Plain-English summary
Zimmer Manufacturing B.V. is recalling specific lots of Versys Advocate Cemented and Versys Advocate V-Lign CE hip implants. The recall involves 4,353 units distributed nationwide in the United States. The affected products are sterile and are intended for use in total or hemi hip arthroplasty.
The recall was initiated because of insufficient sealer calibration data for products packaged in the firm's Building II between August 2010 and April 2013. The source text does not specify the exact nature of the potential harm or report any illnesses or injuries associated with the defect.
Consumers and healthcare providers should check their inventory against the specific lot numbers listed in the official recall notice. If the product matches the affected lots, it should be removed from use and returned to the manufacturer or an authorized representative.
The recalled product
- Product
- Product 66 consists of all product under product code: JDI and same usage: Item no: 785001100 VERSYS ADVOCATE CEMENTED 785001200 VERSYS ADVOCATE CEMENTED 785001220 VERSYS ADVOCATE CEMENTED 785001300 VERSYS ADVOCATE CEMENTED 785001320 VERSYS ADVOCATE CEMENTED 785001400…
- Manufacturer
- Zimmer Manufacturing B.V.
- Affected units
- 4,353
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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