Device product
Persona EM Proximal Tube, orthopedic manual surgical instrument for use with Persona Knee Prosthesis, item 42-5399-001-00, part of the Persona Tibial Resection System.
Z-0410-2016
Product summary
- Firm
- Zimmer, Inc.
- Event
- Event 72714
- Status
- Terminated
- Classification
- Class II
- Quantity
- 156
- Official record key
device-enforcement:Z-0410-2016
Official wording
Reason: Complaints that the ratchet teeth of the tube are not latching onto the rod.
Code information: Proximal Tube Item Number 42-5399-001-00, Lots: 2137111, 62156913, 62222598.
Distribution pattern: Distributed in the states of AZ, CA, ID, IL, IN, KS, MA, MI, MN, MO, NC, NJ, NY, OH, PA, TN, TX, VA, and WA, and the country of Germany.
Derived failure modes
-
Unknown
Complaints that the ratchet teeth of the tube are not latching onto the rod.