FDAClass IIMay 6, 2015

Anatomical Shoulder Handle for Rasp recall

Anatomical Shoulder Handle for Rasp Item: 01.04233.000 Used during total joint arthroplasty of the shoulder.

Why was Anatomical Shoulder Handle for Rasp recalled?

Complaints of difficulties to attach the Anatomical Shoulder Rasps (high resistance) or, once attached, due to difficulties to remove the handle (seizing up of the two components). This has the potential for delay in 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?

Lot Number(s): 13870129 & 13878179.

Product
Anatomical Shoulder Handle for Rasp Item: 01.04233.000 Used during total joint arthroplasty of the shoulder.
Recalling firm
Zimmer Gmbh
Quantity
30 units
Distribution
Distributed to the states of IN, GA, WI, MO, PA, KS, TN, and NY.
Recall date
May 6, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
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