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Recall Observatory FDA recall evidence

Device product

Metasul Femoral Head - indicated for total hip arthroplasty for treatment of patient conditions of non-inflammatory degenerative joint disease.

Z-1136-2015

December 17, 2014

Class II

Product summary

Firm
Zimmer Gmbh
Event
Event 70401
Status
Terminated
Classification
Class II
Quantity
16
Official record key
device-enforcement:Z-1136-2015

Official wording

Reason: Potential compromise of the inner sterile tray. If a compromised tray is detected, a delay in surgery may result. If undetected breach in both the inner and outer trays were to occur, and there is contamination present, a periprosthetic infection is possible, which could lead to revision.

Code information: Item numbers: 734028800 Lot #'s: 61487614

Distribution pattern: Domestic: AK, AL, AR, AZ, CA, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MS, MA, MD, ME, MI, MN, MO, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY International: Canada, Japan

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Potential compromise of the inner sterile tray. If a compromised tray is detected, a delay in surgery may result. If undetected breach in both the inner and outer trays were to occur, and there is contamination present, a periprosthetic infection is possible, which could lead to revision.