Zimmer Biomet Recalls Specific Lots of Trabecular Metal Implants
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.
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 Class II medical device where the hazard is related to the sterile barrier system. While no specific injuries are reported in the source text, the potential loss of sterile integrity in an implant represents a risk of harm (infection) that fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
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 is being conducted because the foil pouches are part of a dual barrier system designed to provide sterile integrity. The source text indicates that the recall is initiated for these specific lots, implying a concern regarding the sterility or integrity of the packaging system.
The recall involves 19,884 total units distributed nationwide and to foreign locations. Consumers and healthcare providers should check their inventory for the specific lot numbers and product codes listed in the official recall notice to determine if they are affected.
The recalled product
- Product
- REV. SHELL LINER 0D 28X48 00700504828 REV. SHELL LINER 10D 28X50 00701005028 REV. SHELL LINER 10D 28X52 00701005228 REV. SHELL LINER 10D 28X54 00701005428 REV. SHELL LINER 10D 28X56 00701005628 REV. SHELL LINER 10D 28X58 00701005828 REV. SHELL LINER 10D 28X6
- 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.
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