Zimmer Biomet Recalls Persona Trabecular Metal Tibial Plate Instruments
Zimmer Biomet is recalling specific Persona Trabecular Metal Tibial Plate Instruments and Modular Brackets due to incidents of radiolucent lines and loosening in implants.
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, and the source text cites 'incidents of radiolucent lines and loosening' without explicitly reporting hospitalizations, deaths, or serious injuries, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Zimmer Biomet, Inc. is initiating a recall of specific Persona Trabecular Metal Tibial Plate Instruments and Modular Brackets. These medical devices are used to facilitate the implantation of joint replacement implants.
The recall is being conducted due to incidents of radiolucent lines and loosening in implants. The affected products were distributed worldwide, including in the United States and various foreign countries such as Australia, New Zealand, and several European nations.
Consumers and healthcare providers should contact Zimmer Biomet for further instructions regarding the recall and the status of their specific devices.
The recalled product
- Product
- Persona Trabecular Metal Tibia; Persona Trabecular Metal Tibial Plate Instruments and Modular Brackets; Used to facilitate the implantation of joint replacement implants.
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 10,256
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 (20)
- Part Number
- Lot Number
- Date of Manufacture: 42509909210
- 63138589
- 07/28/2015
- 42509909210
- 63097616
- 06/10/2015
- 00590708181
- 56595825
- 04/20/2015
- 00590708185
- 56610423
- 03/12/2015
- 00590708176
- 56595826
- 03/04/2015
- 00590708179
- 56595827
- 00590708180
Distribution
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