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