FDAClass IIJune 17, 2020

Biomet 8.0 Cannulated Screw Tap-Bone fixation screw recall

Biomet 8.0 Cannulated Screw Tap-Bone fixation screw Item Number: 110008467 - Product Usage: Intended for temporary internal fixation and stabilization…

Why was Biomet 8.0 Cannulated Screw Tap-Bone fixation screw recalled?

Distributed to the field without having completed design history files or design transfer activities

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 Number: 624830 (01)00887868133749(17)260414(10)624830 867210 (01)00887868133749(17)260730(10)867210

Product
Biomet 8.0 Cannulated Screw Tap-Bone fixation screw Item Number: 110008467 - Product Usage: Intended for temporary internal fixation and stabilization…
Recalling firm
Biomet
Quantity
10 OUS
Distribution
Worldwide distribution - US Nationwide distribution including in the states of NY, GA, FL, MO and the countries of Canada, AUSTRALIA, CHILE, CHINA, JAPAN, MALAYSIA, NETHERLANDS.
Recall date
June 17, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls