FDAClass IIOctober 28, 2015

Thinflap System Case The cases hold surgical recall

Thinflap System Case The cases hold surgical instrumentation in place during handling and storage.

Why was Thinflap System Case The cases hold surgical recalled?

The lids on implant caddies within P/N 17-5000 and 19-5000 could not be opened by the user without application of undesirable/unexpected excessive force.

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 Code # 101465 Model # 19-5000

Product
Thinflap System Case The cases hold surgical instrumentation in place during handling and storage.
Recalling firm
Biomet Microfixation, LLC
Quantity
5 units
Distribution
Nationwide Distribution including CA, FL, OK, NY, NC, and IL.
Recall date
October 28, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls