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 black residue in the packaging. The residue is biocompatible but may cause surgical delays or wear-related intervention.
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 where injury has not yet been reported, but there is a risk of harm (surgical intervention/delay) due to debris, fitting the 'High' severity criteria for risk-of-harm products without reported illness.
Plain-English summary
Zimmer Biomet, Inc. is recalling the Zimmer M/L Taper Hip Prosthesis With Kinectiv Technology Cementless, Size 5 (00-7713-005-00). The recall involves 227 units of the device that were distributed solely to Japan. The affected products were manufactured prior to October 2015.
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. The recalling firm states that the residue is biocompatible.
Risks associated with the recall include the delay of surgery while locating a replacement device and the potential for 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 5; 00-7713-005-00
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 227
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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