Zimmer Biomet Recalls Hip Prostheses Due to Black Residue in Packaging
Zimmer Biomet is recalling specific M/L Taper Hip Prostheses manufactured before October 2015 because black residue was found in the packaging. The residue is a mix of titanium and polyethylene.
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 involves a risk-of-harm product (medical device) where injury has not yet been reported, and the agency classification is Class II without hospitalization reports, fitting the High severity criteria.
Plain-English summary
Zimmer Biomet, Inc. is recalling the Zimmer M/L Taper Hip Prosthesis With Kinective Technology Cementless, Size 15 (00-7713-015-00). The recall affects units manufactured prior to October 2015. A total of 1,024 units were distributed solely to Japan.
The recall is due to the potential for black residue to be observed within the polyethylene bag containing the implant. The firm states that this residue is a combination of the titanium plasma spray used to create the porous surface of the implant and the polyethylene bag. The recalling firm states that the residue is biocompatible.
The identified risks include the delay of surgery while locating a replacement device and potential surgical intervention due to wear caused by debris. No specific instructions for consumers are provided in the source text, as the product was distributed solely to Japan.
The recalled product
- Product
- Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 15; 00-7713-015-00
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 1,024
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 15 recalled by Zimmer Biomet, Inc. 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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Similar recalls
- HighZimmer M/L Taper Hip Prosthesis Recalled Due to Black Residue
FDA (Devices) · 2014-07-16
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