FDAClass IIJuly 11, 2012

Ultima*lx STM recall

ULTIMA*LX STM,POL 10/12TAP/4M Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam…

Why was Ultima*lx STM recalled?

DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on-metal (MoM) articulation (including a head of CoCr and an acetabular cup where the cup is of an all metal construction (monoblock or modular)).The LUSTER Cemented Polished Femoral Hip Stems and the U

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?

Product code: 853159 and Lot numbers: 438756, 438885, 577073, 633711, 660443, 663756, and XCE43.

Product
ULTIMA*LX STM,POL 10/12TAP/4M Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam…
Recalling firm
DePuy Orthopaedics, Inc.
Quantity
431 ULTIMA LX Cemented Polished Femoral Hip Stems in 78 lots
Distribution
Nationwide Distribution-including the states of CA, CO, IA, NC, OH, TX, WA, WI, and WV.
Recall date
July 11, 2012
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls