FDAClass IISeptember 4, 2013

Trial Stem for Mp(r) Reconstruction Prothesis recall

TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/25, Stem size 06, prox. Stem dia. 25 mm, Length 250 mm, WALDEMAR LINK GmbH & CoKG…

Why was Trial Stem for Mp(r) Reconstruction Prothesis recalled?

The trial stems were manufactured using the wrong design.

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: B209035, B225120

Product
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/25, Stem size 06, prox. Stem dia. 25 mm, Length 250 mm, WALDEMAR LINK GmbH & CoKG…
Recalling firm
Waldemar Link GmbH & Co. KG (Corp. Hq.)
Quantity
5 units
Distribution
US Distribution to the state of Tennessee only.
Recall date
September 4, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls