FDAClass IIDecember 4, 2013

REF 200068 Security recall

REF 200068 Security (TM) Enclosed Carpal Tunnel System Blade ( Single) ABS /Stainless Steel Sterile Device, Single Use Only. Designed to release the…

Why was REF 200068 Security recalled?

Security Blades were manufactured oversized and potentially won't advance or may be difficult to advance through the mating Security Clip.

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?

Catalog Number: 200068 Medical Device Listing Number: B008657 Lot Number Identification: 088610, 090600, 143810, 257060, 289900, 365910, 460490, 558300, 626660, 697320,767260,795090,857730,864640,979680

Product
REF 200068 Security (TM) Enclosed Carpal Tunnel System Blade ( Single) ABS /Stainless Steel Sterile Device, Single Use Only. Designed to release the…
Recalling firm
Biomet, Inc.
Quantity
1130
Distribution
Worldwide Distribution: USA (nationwide) and Internationally to Japan.
Recall date
December 4, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
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