FDA Medical Device Recalls (openFDA)
Conformis, Inc.: CONFORMIS HIP-SCREW-6.5MM X 25MM, STERILE EO
- Recall number
- Z-2405-2023
- Recalling firm
- Conformis, Inc.
- Product
- CONFORMIS HIP-SCREW-6.5MM X 25MM, STERILE EO
- Status
- Open, Classified
- Initiated
- 2023-06-16
- Posted
- 2023-08-16
- Terminated
- not on file
- 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.
- Lot, serial or model codes
- Model No. HAA-030-0625-000101; UDI-DI: M572HAA0300625011; Lot No. 1232071.
- 510(k) numbers
- ["K190904","K202484","K221104"]
- PMA numbers
- not on file
- Product code
- OQG
- Firm FEI
- 3009844603
- Firm city
- Billerica
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28