Sterile Distraction Screws of 3 different recall: Sterility Concern
Sterile Distraction Screws of 3 different sizes: 12mm, 14mm and 16mm sold under TSI, 3COR, DB Surgical, and American Surgical Products brands and…
Why was Sterile Distraction Screws of 3 different recalled?
This letter is to notify you that several of our sterile screw products are being voluntarily recalled. Product sterility may be compromised due to a mechanical failure of the protective packaging tube. Tube end plugs may dislodge creating the potential for the screw to come out of the protective tube and then the sharp end of the screw pierce the outer sterile barrier pouch.
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?
Lot numbers: 019715, 019716, 019942, 019943, 019977, 019978, 020102, 020103, 020104, 020105, 020106, 020107, 020108, 020609, 020782, 021539, 021663, 022097, 022098, 022099, 022122, 022123, 022124, 022371, 022372, 022790, 022791, 022792, 022794, 022795, 022796, 022827, 022828, and 023266.
- Product
- Sterile Distraction Screws of 3 different sizes: 12mm, 14mm and 16mm sold under TSI, 3COR, DB Surgical, and American Surgical Products brands and…
- Recalling firm
- Tedan Surgical Innovations Llc
- Quantity
- 12,065 Sterile Distraction Screws (2413 boxes); 384 Sterile XL Screws (128 boxes) in distribution
- Distribution
- Worldwide distribution: USA (nationwide) and countries of : Australia and Taiwan.
- Recall date
- September 26, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)