FDAClass IIJune 24, 2020

Biomet Screw Instrument Tray 6.5/80MM- Surgical Tray recall

Biomet Screw Instrument Tray 6.5/80MM- Surgical Tray Product Code: 246111003

Why was Biomet Screw Instrument Tray 6.5/80MM- Surgical Tray recalled?

Device and tray that houses the device did not pass steam sterilization process validation testing

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?

All lots

Product
Biomet Screw Instrument Tray 6.5/80MM- Surgical Tray Product Code: 246111003
Recalling firm
Biomet
Quantity
705 units
Distribution
Nationwide Foreign: CHINA, AUSTRALIA, CHILE, COSTA RICA , NETHERLANDS, SWITZERLAND
Recall date
June 24, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls