Zimmer Biomet Recalls M/L Taper Hip Prostheses Due to Black Residue
Zimmer Biomet is recalling specific M/L Taper Hip Prostheses manufactured before October 2015 due to potential black residue in the packaging. The residue is described as biocompatible, but risks include surgical delays or wear-related intervention.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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) could lead to injury or surgical intervention, but no illnesses or injuries have been reported in the source text.
Plain-English summary
Zimmer Biomet, Inc. is recalling 116 units of the Zimmer M/L Taper Hip Prosthesis With Kinective Technology Cementless, Size 9 (catalog number 00-7713-009-00). The recall applies to units manufactured prior to October 2015. According to the source, these products were distributed solely to Japan.
The recall is initiated 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 implant's porous surface and the polyethylene bag itself. The recalling firm asserts that the residue is biocompatible.
Identified risks associated with this issue include the delay of surgery while locating a replacement device and the potential for surgical intervention due to wear caused by debris. No specific lot numbers or additional distribution details are provided in the source text beyond the stated quantity and geographic scope.
The recalled product
- Product
- Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 9; 00-7713-009-00
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 116
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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