Zimmer Biomet Recalls M/L Taper Hip Prostheses Due to Black Residue
Zimmer Biomet is recalling M/L Taper Hip Prostheses manufactured before October 2015 due to potential black residue in the packaging. The firm states the residue is biocompatible.
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 high-risk medical device with a risk of harm (surgical intervention due to wear) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Zimmer Biomet, Inc. is recalling 96 units of the Zimmer M/L Taper Hip Prosthesis With Kinectiv Technology Cementless, Size 6 (00-7713-006-00). The recall affects units manufactured prior to October 2015. These products 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 company states that the residue is a combination of the titanium plasma spray used to create the porous surface of the implant and the polyethylene bag. Zimmer Biomet 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 products were distributed to Japan.
The recalled product
- Product
- Zimmer¿ M/L Taper Hip Prosthesis With Kinectiv¿ Technology Cementless, Size 6; 00-7713-006-00
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 96
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)
- 62044925 62571340 62831345 62869740 62953032 63068885 63081184 63089967
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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