Device product
Continuum Acetabular System Trabecular Metal Shell with Multi Holes, Porous 68mm, Prosthesis, Hip, Semi-Constrained, Metal/Polymer
Z-0094-2015
Product summary
- Firm
- Zimmer, Inc.
- Event
- Event 69301
- Status
- Terminated
- Classification
- Class II
- Quantity
- 19
- Official record key
device-enforcement:Z-0094-2015
Official wording
Reason: The affected products are missing polar boss threads.
Code information: Part Number: 00-8757-068-02; Lot Number: 62207029
Distribution pattern: Worldwide Distribution: US (nationwide) in the states of : IA, CA, NC, AL, WA, FL, TN, MA, AZ, TX, UT, and NV; and Internationally to Japan.
Derived failure modes
-
Unknown
The affected products are missing polar boss threads.