Recall Z-2405-2023 · OQG Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented
Conformis, Inc.
CONFORMIS HIP-SCREW-6.5MM X 25MM, STERILE EO
| Date | Aug 16, 2023 (initiated Jun 16, 2023) |
| Status | Open, Classified |
| Reason | 30mm screws were labeled as 25mm screws. |
| Root cause | Error in labeling |
| Action | 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. |
| Quantity | 25 units |
| Distribution | US Nationwide distribution in the states of CA, FL, GA, KS, MA, NV, NY, TN, & VA. |
| FDA record | Open on fda.gov |