FDAClass IIJanuary 16, 2013

Accolade TMZF Plus 127 degree Neck Angle V40 Hip Stem recall

Accolade TMZF Plus 127 degree Neck Angle V40 Hip Stem #2.5 and Accolade TMZF Plus 127 degree Neck Angle V40 Hip Stem #3.5, Howmedica Osteonics Corp.…

Why was Accolade TMZF Plus 127 degree Neck Angle V40 Hip Stem recalled?

Stryker has received a report that single size 3.5 stem was packaged as size 2.5 stem resulting in a possible product mix.

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?

Catalog Number: 6021-2530 Lot #40264005 Catalog Number: 6021-3535 Lot #40163005. This lot was not received in the US.

Product
Accolade TMZF Plus 127 degree Neck Angle V40 Hip Stem #2.5 and Accolade TMZF Plus 127 degree Neck Angle V40 Hip Stem #3.5, Howmedica Osteonics Corp.…
Recalling firm
Stryker Howmedica Osteonics Corp.
Quantity
6021-2530- four units; 6021-3535-
Distribution
Nationwide distribution, including the states of NY, NJ, CA and FL.
Recall date
January 16, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls