Zimmer Recalls ZIMTRON 6 DEG 22 Heads Due to Packaging Validation Issues
Zimmer, Inc. is recalling ZIMTRON 6 DEG 22 Heads because packaging operations at a Puerto Rico facility were not properly validated, raising concerns about 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 with a potential risk to sterile barrier integrity, which is a high-risk hazard where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Zimmer, Inc. is recalling ZIMTRON 6 DEG 22 Heads. The recall involves 7,044,680 units distributed worldwide, including the United States and numerous international markets such as Belgium, Canada, China, France, Germany, India, Japan, and the United Kingdom.
The recall was initiated after Zimmer reviewed historic packaging validations at its Zimmer Manufacturing B.V. facility in Ponce, Puerto Rico. The review determined that packaging operations in Building 1 were not properly validated. Although subsequent seal integrity testing indicated that the packaging trays met acceptance criteria for sterile barrier integrity, Zimmer decided to recall all non-expired lots sterile packaged in that specific facility to ensure safety.
Healthcare professionals and patients who have received or used these devices should contact Zimmer, Inc. for further instructions on how to return or replace the product. The recall number is Z-1030-2014.
The recalled product
- Product
- ZIMTRON 6 DEG 22 HEADS
- Manufacturer
- Zimmer, Inc.
- Hazard
- Affected units
- 7,044,680
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)
- 61841123
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 44 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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