Zimmer Recalls ITST Threaded Guide Pins Due to Sterility Concerns
Zimmer, Inc. is recalling ITST Threaded Guide Pins because testing found that a specific packaging tray configuration failed to maintain sterile barrier 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 medical device where sterile barrier integrity failed, creating a risk of infection. This fits the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Zimmer, Inc. is recalling 42,065 units of ITST Threaded Guide Pins. The recall affects Item Number 47-2258-067-00 with expiration dates prior to July 24, 2023. These products 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. Testing determined that a packaging tray configuration consisting of an inner and outer sterile tray resulted in failure.
Healthcare providers and facilities should stop using the affected ITST Threaded Guide Pins and contact Zimmer, Inc. for instructions on how to return the product.
The recalled product
- Product
- ITST THREADED GUIDE PIN
- 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 (2)
- Item Numbers: 47-2258-067-00 All Lots with an expiration date prior to July 24
- 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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