Device product
Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
Z-0034-2022
Product summary
- Event
- Event 88724
- Status
- Terminated
- Classification
- Class II
- Quantity
- 77 kits
- Official record key
device-enforcement:Z-0034-2022
Official wording
Reason: Product kit missing CDG 200 (Cannulated Countersink for 3.0-4.5mm Screws) from EWK 201 (Flower E-Kit, Advanced)
Code information: Lot Number: 2104321637 Unique Identifier: 00840118112079
Distribution pattern: US Nationwide distribution in the states of AZ, CA, CO,CT, FL, IL, IN, NC, NY, NV, OH, WV, TX.
Derived failure modes
-
Unknown
Product kit missing CDG 200 (Cannulated Countersink for 3.0-4.5mm Screws) from EWK 201 (Flower E-Kit, Advanced)