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Recall Observatory FDA recall evidence

Device product

Tennis Elbow Support, Neoprene***LATEX FREE" Product Usage: Provides compression and warmth for mild to moderate elbow strains and sprains.

Z-1606-2014

March 19, 2014

Class II

Product summary

Firm
Zimmer, Inc.
Event
Event 68017
Status
Terminated
Classification
Class II
Quantity
649 units
Official record key
device-enforcement:Z-1606-2014

Official wording

Reason: During a transfer of products from a recently shutdown facility, the firm discovered raw material labeled as latex free actually contained latex.

Code information: Model #: 00-3448-003-00 through 00-3448-006-00

Distribution pattern: Worldwide Distribution - US Nationwide in the states of: AK, AZ, CA, FL, GA, IA, IL, IN, LA, MD, MI, MO NC, NE, NV, NY, OH, OK, OR, PA, RI, SD, TX, UT, VA, VT, WA, WI & WV and countries of: AUSTRALIA, CANADA, GERMANY, IRAQ, ITALY, SAUDI ARABIA, TUNISIA & UNITES ARAB EMIRATES.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    During a transfer of products from a recently shutdown facility, the firm discovered raw material labeled as latex free actually contained latex.