Zimmer Recalls Tibio Fem/Fem Nail Due to Sterile Barrier Integrity Failure
Zimmer, Inc. is recalling 42,065 units of Tibio Fem/Fem Nail because testing revealed a packaging tray configuration that failed sterile barrier integrity requirements.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly identifies the recall as Class II. According to the rubric, FDA Class II recalls are classified as Severe (Score 4), particularly when involving structural or integrity failures in medical devices.
Plain-English summary
Zimmer, Inc. is recalling 42,065 units of Tibio Fem/Fem Nail implants. The recall covers item numbers 32-8553-311-11, 32-8553-311-13, 32-8553-311-15, and 32-8553-311-17, specifically all lots with an expiration date prior to July 24, 2023. The products were distributed worldwide.
The recall was initiated after a review of historic packaging validations determined that a subset of product packaged at a Zimmer facility required testing to ensure it met established requirements for sterile barrier integrity. Testing revealed that a specific packaging tray configuration, consisting of an inner and outer sterile tray, resulted in failure.
This is a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences. Healthcare providers and patients should contact Zimmer, Inc. for further instructions regarding the affected units.
The recalled product
- Product
- TIBIO FEM/FEM NAIL.
- Manufacturer
- Zimmer, Inc.
- Hazard
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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