Zimmer Biomet Recalls M/L Taper Hip Prostheses Due to Black Residue
Zimmer Biomet is recalling 84 M/L Taper Hip Prostheses with Kinective Technology due to black residue 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 (debris causing wear) presents a risk of harm requiring surgical intervention, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Zimmer Biomet, Inc. is recalling 84 units of the M/L Taper Hip Prosthesis with Kinective Technology Cementless, Size 12.5 (Catalog No. 00-7713-012-00). The recall involves devices manufactured prior to October 2015. The 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 the 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.
Risks associated with this recall include the delay of surgery while locating a replacement device and potential 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 With Kinective¿ Technology Cementless, Size 12.5; 00-7713-012-00
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 84
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 61741690 62808128 62831371 63068944 63090038 63094522 63128589
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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