Device product
CONFORMIS HIP-SCREW-6.5MM X 25MM, STERILE EO
Z-2405-2023
Product summary
- Firm
- Conformis, Inc.
- Event
- Event 92764
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 25 units
- Official record key
device-enforcement:Z-2405-2023
Official wording
Reason: 30mm screws were labeled as 25mm screws.
Code information: Model No. HAA-030-0625-000101; UDI-DI: M572HAA0300625011; Lot No. 1232071.
Distribution pattern: US Nationwide distribution in the states of CA, FL, GA, KS, MA, NV, NY, TN, & VA.
Derived failure modes
-
Unknown
30mm screws were labeled as 25mm screws.