Zimmer Biomet Recalls M/L Taper Hip Prostheses Due to Black Residue
Zimmer Biomet is recalling 510 M/L Taper Hip Prostheses distributed to Japan due to potential black residue in the packaging.
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 is classified as FDA Class II. The source text identifies risks of surgical intervention and delay but does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Zimmer Biomet, Inc. is recalling 510 units of the Zimmer M/L Taper Hip Prosthesis With Kinective Technology Cementless, Size 13.5 (catalog number 00-7713-013-00). The recall affects devices 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 firm 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. The recalling firm 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 solely to Japan.
The recalled product
- Product
- Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 13.5; 00-7713-013-00
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 510
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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