FDAClass IIMay 25, 2016

Hgp ii acetabular cup bone screw selftap 6.5x15mm recall

Hgp ii acetabular cup bone screw selftap 6.5x15mm 00662406515 Hgp ii acetabular cup bone screw selftap 6.5x20mm 00662406520 Hgp ii acetabular cup bone…

Why was Hgp ii acetabular cup bone screw selftap 6.5x15mm recalled?

A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.

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?

LOTS: 63276979 63276976 63245682 63276975 63276977 63301523 63276980 63303436

Product
Hgp ii acetabular cup bone screw selftap 6.5x15mm 00662406515 Hgp ii acetabular cup bone screw selftap 6.5x20mm 00662406520 Hgp ii acetabular cup bone…
Recalling firm
Zimmer Manufacturing B.V.
Quantity
1199
Distribution
Worldwide distribution. US nationwide, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador, Australia, India, Hong Kong, Chile, Germany, Italy, France, Spain, UK, Sweden, Canada.
Recall date
May 25, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls