Device product
Drill, cannulated, 2x95mm, round shaft, Item Number ST502015619
Z-1476-2019
Product summary
- Firm
- Zimmer GmbH
- Event
- Event 82642
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-1476-2019
Official wording
Reason: An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Code information: All items marked with "Normed" are affected
Distribution pattern: 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.
Derived failure modes
-
Unknown
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.