Zimmer Avenir Moller Hip Stem Recall Due to Packaging Mix-up
Zimmer GmbH is recalling two Avenir Moller hip stem models due to a packaging mix-up that could lead to the use of the incorrect implant.
What this means for you
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 involves a risk-of-harm product (medical device) where the use of an incorrect implant could lead to patient injury (dismetry) and the need for revision surgery, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Zimmer GmbH is recalling two specific models of the Avenir Moller hip joint prosthesis: the Avenir Moller Stem 4 Standard (Item Number 01.06010.004, Lot Number 4022860) and the Avenir Moller Stem 6 Lateral (Item Number 01.06010.106, Lot Number 4023094). The recall involves two units of these medical devices.
The recall was initiated due to a product mix-up where the Avenir Moller Stem 6 lateral uncemented implant might be placed in the packaging of the Avenir Moller Stem 4 standard uncemented implant, and vice versa. This error creates a potential for delay in surgery and the use of an incorrect implant, which may lead to dismetry in the patient and possibly the need for revision surgery.
The affected products were distributed nationwide to Ohio and New Mexico. Healthcare providers and facilities that have received these specific lots should stop using the products and contact the recalling firm for instructions on return or replacement.
The recalled product
- Product
- Avenir M¿ller Stem 4 Standard Avenir M¿ller Stem 6 Lateral Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Intended Use: " Advanced wear of the joint due to degenerative, post-traumatic or rheumatic diseases. " Failed previous hi
- Manufacturer
- Zimmer Gmbh
- Affected units
- 2
Distribution
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