Zimmer Recalls NGK Stem Extenders Due to Sterile Barrier Integrity Failures
Zimmer, Inc. is recalling NGK Stem Extenders because testing revealed 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 failure in sterile barrier integrity for a medical device, which poses a risk of infection (harm) even though no specific illnesses or injuries are reported in the source text.
Plain-English summary
Zimmer, Inc. is recalling 42,065 units of NGK Stem Ext 24 x 245mm (Item Number 32-5988-012-24) with expiration dates prior to July 24, 2023. The recall affects products 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 devices and contact Zimmer, Inc. for further instructions on the recall process.
The recalled product
- Product
- NGK Stem Ext 24 x 245mm
- 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: 32-5988-012-24 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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