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 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 due to wear) and operational risk (surgery delay). This aligns with 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 Kinective Technology Cementless, Size 11 (00-7713-011-00). The recall affects 132 units of the device 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. According to the recalling firm, the residue is a combination of the titanium plasma spray used to create the porous surface of the implant and the polyethylene bag. The firm states that the residue is biocompatible.
The identified risks include the delay of surgery while locating a replacement device and the potential for surgical intervention due to wear caused by debris. No specific illnesses or injuries are reported in the source text.
The recalled product
- Product
- Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 11; 00-7713-011-00
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 132
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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