FDA Recall
Terminated
CBS 7.5 tap, cannulated, AO, Item Number 503002041
Recall: Z-1453-2019
·
Initiated April 8, 2019
Recall
- Recall Number
- Z-1453-2019
- Event Number
- 82642
- Firm
- Zimmer GmbH Sulzerallee 8 Winterthur Switzerland
- FEI Number
- 3005233524
- Product Code
- HWX
- Status
- Terminated
- Root Cause
- Under Investigation by firm
- Initiated
- April 8, 2019
- Terminated
- May 11, 2020
Description
CBS 7.5 tap, cannulated, AO, Item Number 503002041
Reason
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Action
Urgent Medical Device Recall notification letters dated 4/8/19 were sent to customers.
Distribution
The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.