Device product
RECLAIM Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.
Z-2082-2014
Product summary
- Event
- Event 68440
- Status
- Terminated
- Classification
- Class II
- Quantity
- 814 units
- Official record key
device-enforcement:Z-2082-2014
Official wording
Reason: The product can be difficult to remove from the Distal Stem both out of the package and after proximal reaming.
Code information: Product # 297500110 Lot # 126559; 126569, 181990, 181995, 224156, 231487, 240683, 260366, 260370, 272820, 272827, 272831 & 272836.
Distribution pattern: 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.
Derived failure modes
-
Unknown
The product can be difficult to remove from the Distal Stem both out of the package and after proximal reaming.