Zimmer Trabecular Metal Implants Recalled for Sterility Concerns
Zimmer Biomet is recalling specific lots of sterile Trabecular Metal implants manufactured between April 2011 and October 2012 due to potential issues with the foil pouches used for sterile integrity.
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 risk-of-harm product (sterile implant) where injury has not yet been reported, fitting the 'High' severity criteria for potential harm without confirmed illness.
Plain-English summary
Zimmer Biomet is initiating a recall of specific lots of foil pouched, sterile Trabecular Metal implants. The affected products were manufactured between April 2011 and October 2012. The recall involves 19,884 total units distributed nationwide and foreign.
The recall is being initiated because the foil pouches, which are part of a dual barrier system designed to provide sterile integrity, may be compromised. This could potentially affect the sterility of the implants.
Healthcare providers and facilities that have received these specific lots should stop using them and contact Zimmer Biomet for instructions on how to return the products. Patients who have already had these implants placed should consult their healthcare provider for guidance.
The recalled product
- Product
- TM MONO TIB STR GRN SZ 5 - 00588606510 TM MONO TIB STR GRN SZ 5 12MM - 00588606512 TM MONO TIB STR GRN SZ 5 14MM - 00588606514 TM MONO TIB STR GRN SZ 5 17MM - 00588606517 TM MONO TIB STR GRN SZ 6 10MM - 00588606610 TM MONO TIB STR GRN SZ 6 12MM - 00588606612 TM…
- Manufacturer
- Zimmer Trabecular Metal Technology, Inc.
- Hazard
- Affected units
- 19,884
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Zimmer Trabecular Metal Technology, 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.
See all 6 products in this recall →Related recalls
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