CONFORMIS HIP-SCREW-6.5MM X 25MM, STERILE EO
- Company
- Conformis, Inc.
- Recall Initiated
- June 16, 2023
- Posted
- August 16, 2023
- Recall Number
- Z-2405-2023
- Quantity
- 25 units
- Firm Location
- Billerica, MA
Reason for Recall
30mm screws were labeled as 25mm screws.
Distribution
US Nationwide distribution in the states of CA, FL, GA, KS, MA, NV, NY, TN, & VA.
Lot / Code Info
Model No. HAA-030-0625-000101; UDI-DI: M572HAA0300625011; Lot No. 1232071.
Root Cause
Error in labeling
Action Taken
The firm initially notified the surgeon who possessed affected devices of this recall event via telephone and subsequently by email on 7/12/2023. The surgeon mailed back all affected product to Conformis to be quarantined. Sales representatives were informed of this recall event and sent all affected devices in their possession back to Conformis to be quarantined.
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