Device product
Alpen Clinic 100 Carbide Instruments (R100057C)
Z-0464-2021
Product summary
- Event
- Event 86694
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 556 packs
- Official record key
device-enforcement:Z-0464-2021
Official wording
Reason: The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the FG 57 burs.
Code information: J75023
Distribution pattern: Sold to distributors located in FL, NV, PA, TN, TX. Foreign distribution to Canada.
Derived failure modes
-
Unknown
The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the FG 57 burs.