Various trauma and sports medicine instruments and recall: Sterility Concern
Various trauma and sports medicine instruments and implants. Pin, fixation, smooth.
Why was Various trauma and sports medicine instruments and recalled?
Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the product becomes non-sterile and is used or implanted, it may lead to an infection.
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?
Part #'s 24415 24416 27914 27922 328010 14-401440 14-450360 14-450365 14-450380 14-450390 35-361681 Lot #'s 679900 693860 729090 722660 668350 591000 591010 591020 652700 745110 752860 728860 652650 664410 664440 606280
- Product
- Various trauma and sports medicine instruments and implants. Pin, fixation, smooth.
- Recalling firm
- Biomet, Inc.
- Quantity
- N/A
- Distribution
- Worldwide Distribution - US (Nationwide) and globally to Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Ecaudor, The Netherlands, Japan, Korea, Malaysia, Mexico, Peru.
- Recall date
- June 1, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)