Zimmer Recalls Tibia Nails Due to Sterile Barrier Integrity Failures
Zimmer, Inc. is recalling 42,065 Tibia Nails because testing revealed that a specific packaging tray configuration failed to maintain sterile barrier 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 medical device with a sterile barrier integrity failure, which poses a risk of harm (infection) even though no injuries or illnesses have been reported in the source text.
Plain-English summary
Zimmer, Inc. is recalling 42,065 units of Tibia Nails. 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 determined that a packaging tray configuration, which consists of an inner and outer sterile tray, resulted in failure. The affected products are identified by Item #s 32-8553-311-59, 32-8553-311-61, 32-8553-311-63, and 32-8553-311-65. The recall includes all lots with an expiration date prior to July 24, 2023.
The products were distributed worldwide. The source text does not specify specific actions for consumers or healthcare providers, nor does it report any illnesses or injuries associated with the recall.
The recalled product
- Product
- TIB NAIL
- 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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