Conformis, Inc. CONFORMIS HIP-SCREW-6.5MM X 25MM, STERILE EO Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
CONFORMIS HIP-SCREW-6.5MM X 25MM, STERILE EO
Brand
Conformis, Inc.
Lot Codes / Batch Numbers
Model No. HAA-030-0625-000101, UDI-DI: M572HAA0300625011, Lot No. 1232071.
Products Sold
Model No. HAA-030-0625-000101; UDI-DI: M572HAA0300625011; Lot No. 1232071.
Conformis, Inc. is recalling CONFORMIS HIP-SCREW-6.5MM X 25MM, STERILE EO due to 30mm screws were labeled as 25mm screws.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
30mm screws were labeled as 25mm screws.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026