Z-2405-2023 Class II Ongoing
FDA device recall Z-2405-2023 was initiated by Conformis, Inc. on June 16, 2023 and is designated Class II. Reason for recall: 30mm screws were labeled as 25mm screws. The recall status is ongoing. Affected quantity: 25 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 23, 2023
- Initiation Date
- June 16, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 25 units
Product Description
CONFORMIS HIP-SCREW-6.5MM X 25MM, STERILE EO
Reason for Recall
30mm screws were labeled as 25mm screws.
Distribution Pattern
US Nationwide distribution in the states of CA, FL, GA, KS, MA, NV, NY, TN, & VA.
Code Information
Model No. HAA-030-0625-000101; UDI-DI: M572HAA0300625011; Lot No. 1232071.