FDAClass IIJune 25, 2014

EZPass Suture Retriever recall

EZPass Suture Retriever, Nitinol, Single Pack, Part number 10007380. Orthopedic Manual Surgical Instrument, Sterile, single use arthroscopic…

Why was EZPass Suture Retriever recalled?

The nitinol wire or monofilament may buckle within the EZPass Suture Passer and become kinked making the wire/monofilament difficult to use.

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 numbers 110007380 Lot 223570 and 803860

Product
EZPass Suture Retriever, Nitinol, Single Pack, Part number 10007380. Orthopedic Manual Surgical Instrument, Sterile, single use arthroscopic…
Recalling firm
Biomet, Inc.
Quantity
100 units
Distribution
Nationwide Distribution.
Recall date
June 25, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
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