FDAClass IIJune 5, 2013

Ball Head recall

Ball Head, 28 Short CERAMIC Ball Head, 28 Medium CERAMIC Ball Head, 28 Long CERAMIC Ball Head, 32 Short CERAMIC Ball Head, 32 Medium CERAMIC Ball…

Why was Ball Head recalled?

The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were not being provided to every physician and for every surgery.

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 No. 194.01.28 194.02.28 194.03.28 195.01.32 195.02.32 195.03.32 188.01.28 188.02.28 188.03.28 188.04.28 188.05.28 189.01.32 189.02.32 189.03.32

Product
Ball Head, 28 Short CERAMIC Ball Head, 28 Medium CERAMIC Ball Head, 28 Long CERAMIC Ball Head, 32 Short CERAMIC Ball Head, 32 Medium CERAMIC Ball…
Recalling firm
Orthopedic Alliance LLC
Quantity
26 units
Distribution
Nationwide Distribution including the states of CA, MD, TX, NV, and WI.
Recall date
June 5, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls