Zimmer Biomet Recalls 24 Hip Prosthesis Units Distributed to Japan
Zimmer Biomet is voluntarily recalling 24 hip prosthesis units distributed solely to Japan. The recall was initiated in May 2018 and terminated in May 2020.
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 is classified as FDA Class II. Per the rubric, risk-of-harm products where injury has not yet been reported are assigned a score of 3 (High).
Plain-English summary
Zimmer Biomet, Inc. is voluntarily recalling 24 units of the Zimmer M/L Taper Hip Prosthesis With Kinective Technology Cementless, Size 10 (catalog number 00-7713-010-00). The recall was initiated on May 30, 2018, and was classified as Class II by the U.S. Food and Drug Administration.
According to the source text, the products were distributed solely to Japan. The recall status is listed as Terminated, with a termination date of May 28, 2020. The source does not specify the reason for the recall or report any illnesses or injuries associated with the device.
Consumers or healthcare providers with these specific units should contact Zimmer Biomet for further instructions. The recall was initiated by the firm and notified via email.
The recalled product
- Product
- Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 10; 00-7713-010-00
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 24
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)
- 62361460 62528141
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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