Zimmer Biomet Recalls M/L Taper Hip Prostheses Due to Black Residue
Zimmer Biomet is recalling specific M/L Taper Hip Prostheses manufactured before October 2015 due to black residue found 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 the hazard (wear caused by debris) poses a risk of harm, but the source text does not report any actual injuries or illnesses, fitting the criteria for a High severity score.
Plain-English summary
Zimmer Biomet, Inc. is recalling 101 units of the Zimmer M/L Taper Hip Prosthesis With Kinective Technology Cementless, Size 22.5 (Catalog Number 00-7713-022-00). The recall affects devices manufactured prior to October 2015. These specific 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 company 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 itself. Zimmer Biomet asserts 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. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 22.5; 00-7713-022-00
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 101
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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