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 described as 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 requiring surgical intervention, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Zimmer Biomet, Inc. is recalling 280 units of the Zimmer M/L Taper Hip Prosthesis Plasma Sprayed, Size 4 Extended Offset (model 00-7711-004-40). The recall covers M/L Taper Hip Prostheses and M/L Taper Hip Prostheses with Kinectiv Technology manufactured prior to October 2015. These products were distributed solely to Japan.
The recall is issued due to the potential for black residue to be observed within the polyethylene bag containing the implant. The recalling 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 firm asserts that the residue is biocompatible.
The identified risks include the delay of surgery while locating a replacement device and the potential need for surgical intervention due to wear caused by debris. Consumers and healthcare providers should contact Zimmer Biomet for further instructions regarding the replacement of these devices.
The recalled product
- Product
- Zimmer M/L Taper Hip Prosthesis Plasma Sprayed, Size 4 Extended Offset, 00-7711-004-40
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 280
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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