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 (hip prosthesis) where the hazard (debris causing wear) presents a risk of harm requiring surgical intervention, but no injuries or illnesses have been reported, fitting the 'High' criteria for risk-of-harm products without reported injury.
Plain-English summary
Zimmer Biomet, Inc. is recalling the Zimmer M/L Taper Hip Prosthesis With Kinective Technology Cementless, Size 16.25 (catalog number 00-7713-016-00). The recall affects 665 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 recalling firm states that 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.
Risks associated with this recall 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 16.25; 00-7713-016-00
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 665
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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