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Recall Observatory FDA recall evidence

Device product

4.5 mm Malleolar Screw Sterile zimmer

Z-2250-2014

July 22, 2014

Class II

Product summary

Firm
Zimmer, Inc.
Event
Event 68819
Status
Terminated
Classification
Class II
Quantity
47,682 units total
Official record key
device-enforcement:Z-2250-2014

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 47-4845-025, 030, 035, 040, 050, 055, 060, 065, 070, -08

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

    reason.no_named_rule · v1.0.0

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

Field note

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