Recalls / —

—#128987

Product

4.0 mm Cancellous Screw, Partially Threaded Sterile Zimmer

FDA product code

HWC — Screw, Fixation, Bone

Device class

Class 2

Medical specialty

Orthopedic

510(k) numbers

K112885

Affected lot / code info

Item Number 47-4840-010, 012, 014, 016, 018, 020, 022, 024, 026, 028, 030, 035, 040, 045, 050, 055, 060, 065, 070, 075, 080, 085, 090, 095, 100-01

Why it was recalled

Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only.

Root cause (FDA determination)

Package design/selection

Action the firm took

On 7/22/14, Zimmer sent recall notification to the consignees explaining the issue, identifying affected product, providing the health risks, and instructing the consignees what to do for the recall. Questions or concerns, please contact Zimmer at 1-877-946-2761.

Recalling firm

Firm

Zimmer, Inc.

Address

1800 W Center St, Warsaw, Indiana 46580-2304

Distribution

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

Timeline

Recall initiated

2014-07-22

Posted by FDA

2014-08-16

Terminated

2015-06-18

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #128987. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.