Zimmer Biomet Recalls Hip Prostheses Due to Black Residue in Packaging
Zimmer Biomet is recalling specific M/L Taper Hip Prostheses because black residue was found in the polyethylene packaging. The firm states the residue is biocompatible, but it 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 (debris causing wear or surgical delay) presents a risk of harm, but the source text does not report any actual illnesses or injuries, fitting the criteria for a score of 3.
Plain-English summary
Zimmer Biomet, Inc. is recalling 138 units of the Zimmer M/L Taper Hip Prosthesis With Kinective Technology Cementless, Size 20 (catalog number 00-7713-020-00). The recall involves 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 explains 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 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 20; 00-7713-020-00
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 138
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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