Zimmer Recalls Femoral Condylar Buttress Plates Due to Sterility Concerns
Zimmer, Inc. is recalling specific femoral condylar buttress plates because testing revealed a packaging configuration that failed sterile barrier integrity requirements.
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 is classified as FDA Class II, and the hazard involves a sterile barrier integrity failure in a medical device, which poses a risk of infection or harm even if specific injuries are not yet reported in the text.
Plain-English summary
Zimmer, Inc. is recalling 42,065 units of FEM COND BUTTRESS PLT, RT. (Femoral Condylar Buttress Plate, Right). The affected products are identified by item numbers 00-2347-001-12, 00-2347-001-14, 00-2347-001-16, and 00-2347-001-18. The recall includes all lots with an expiration date prior to July 24, 2023. These devices were distributed worldwide.
The recall was initiated after a review of historic packaging validations indicated that a subset of product packaged at a Zimmer facility required testing to ensure it met established requirements for sterile barrier integrity. Subsequent testing determined that a specific packaging tray configuration, consisting of an inner and outer sterile tray, resulted in failure.
This is a Class II recall, which means the use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences. Healthcare providers and facilities should stop using the affected devices and contact Zimmer, Inc. for instructions on return or replacement.
The recalled product
- Product
- FEM COND BUTTRESS PLT, RT.
- Manufacturer
- Zimmer, Inc.
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)
- 2023
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 8 recalled by Zimmer, 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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