Various trauma and sports medicine instruments and recall: Sterility Concern
Various trauma and sports medicine instruments and implants. Rod, fixation, intramedullary and accessories.
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 28234 28338 28811 28813 28821 29260 29822 805065080 14-400428 14-400436 14-405032 14-405040 14-440118 14-440121 14-441280 14-440066S Lot #'s 590970 591080 591090 665210 692040 692250 692280 692290 695900 610470 665230 665240 692440 692450 692480 692620 692660 692670 692690 721680 721720 721730 729080 722730 621840 621860 678300 664740 664820 664870 664880 503760 503770 693840 476230
- Product
- Various trauma and sports medicine instruments and implants. Rod, fixation, intramedullary and accessories.
- 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)