CONFORMIS HIP-SCREW-6.5MM X 25MM, STERILE EO
FDA device recall Z-2405-2023 · posted 2023-08-16 · Open, Classified
Recall details
- Recalling firm
- Conformis, Inc.
- Reason for recall
- 30mm screws were labeled as 25mm screws.
- 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.
- Root cause
- Error in labeling
- Status
- Open, Classified
- Product code
- OQG
- Quantity affected
- 25 units
- Distribution
- US Nationwide distribution in the states of CA, FL, GA, KS, MA, NV, NY, TN, & VA.
- Date initiated
- 2023-06-16
- Date posted
- 2023-08-16
- Location
- Billerica, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Actera™ hip system (K221104) | Conformis, Inc. | 2022-08-04 |
| Cordera Hip System (K202484) | Conformis, Inc. | 2020-09-24 |
| Conformis BeneFIT Hip System (K190904) | Conformis, Inc. | 2019-08-28 |