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Recall Observatory FDA recall evidence

Device product

Cartilage Knee Brace***LATEX FREE" Product Usage: Used in the treatment and support of many types of knee injuries or following surgical and nonsurgical correction.

Z-1604-2014

March 19, 2014

Class II

Product summary

Firm
Zimmer, Inc.
Event
Event 68017
Status
Terminated
Classification
Class II
Quantity
2,222 units
Official record key
device-enforcement:Z-1604-2014

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 #: 00-1747-001-00 through 00-1747-005-00

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.