Dist LAT FEM Lock PLT recall: Sterility Concern
DIST LAT FEM LOCK PLT, LT
Why was Dist LAT FEM Lock PLT recalled?
Based on a review of historic packaging validations, it was determined that a subset of product packaged at a Zimmer facility required testing to ensure that previously packaged product from this facility met the established requirements for sterile barrier integrity. This testing determined that a packaging tray configuration which consists of an inner and outer sterile tray, resulted in failure
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Item Number: 47-2357-102-14 47-2357-102-18 All lots with an expiration date prior to July 24, 2023
- Product
- DIST LAT FEM LOCK PLT, LT
- Recalling firm
- Zimmer, Inc.
- Quantity
- 42, 065 units total
- Distribution
- Worldwide Distribution.
- Recall date
- January 8, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)