FDAClass IIJuly 30, 2014

RECLAIM Taper Protector Sleeve. RECLAIM Revision Hip recall

RECLAIM Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the…

Why was RECLAIM Taper Protector Sleeve. RECLAIM Revision Hip recalled?

The product can be difficult to remove from the Distal Stem both out of the package and after proximal reaming.

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 # 297500110 Lot # 126559; 126569, 181990, 181995, 224156, 231487, 240683, 260366, 260370, 272820, 272827, 272831 & 272836.

Product
RECLAIM Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the…
Recalling firm
DePuy Orthopaedics, Inc.
Quantity
814 units
Distribution
Worldwide Distribution - USA including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI & WV and Internationally to AUSTRALIA, AUSTRIA, CANADA, CHILE, CHINA, CZECH REPUBLIC, DENMARK, FRANCE, GERMANY, IBERIA, IRELAND, ISRAEL, ITALY, NEW ZEALAND, NORWAY, POLAND, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWITZERLAND & UK.
Recall date
July 30, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
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