Device product
Magna-Fx Cannulated Screw Fixation System Cannulated Bone Screw Sterile zimmer
Z-2245-2014
Product summary
- Firm
- Zimmer, Inc.
- Event
- Event 68819
- Status
- Terminated
- Classification
- Class II
- Quantity
- 47,682 units total
- Official record key
device-enforcement:Z-2245-2014
Official wording
Reason: Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only.
Code information: Item Number 00-1146-040, 045, 050, 055, 060, 065, 070, 075, 080, 085, 090, 095, 100-32
Distribution pattern: National Distribution: AK, AL, AZ, CA, CT, DC, FL, GA, US VIRGIN ISLANDS, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, VA, WA, WI, WV, WY Foreign Distribution: Canada, Mexico, ARGENTINA, AUSTRALIA, BELGIUM,BRAZIL, CHINA, EL SALVADOR, ENGLAND, GERMANY, INDIA, ITALY, JAPAN, JORDAN, KOREA, NEW ZEALAND, SAUDI ARABIA, SINGAPORE, SPAIN, SWITZERLAND, TAIWAN, UAE
Derived failure modes
-
Unknown
Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only.