Z-2405-2023Class II

Conformis Hip-Screw-6.5Mm X 25Mm, Sterile Eo

Name: Z-2405-2023 Conformis Hip-Screw-6.5Mm X 25Mm, Sterile Eo
Creator: Conformis, Inc.
Published: 2023-06-16
License: https://open.fda.gov/license/

ConforMIS, Inc. / initiated 2023-06-16 / Open, Classified / root cause: labeling and UDI

FDA source

Conformis, Inc. began a recall of CONFORMIS HIP-SCREW-6.5MM X 25MM, STERILE EO on 2023-06-16. FDA classified it as Class II and gives the reason as "30mm screws were labeled as 25mm screws". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2405-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-06-16
Posted: 2023-08-16
Recalling firm: ConforMIS, Inc.
Product: Conformis Hip-Screw-6.5Mm X 25Mm, Sterile Eo
Product code: OQG Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented
Reason for recall: 30mm screws were labeled as 25mm screws.
Root cause tag: labeling and UDI
FDA 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 in commerce: 25 units
Distribution: US Nationwide distribution in the states of CA, FL, GA, KS, MA, NV, NY, TN, & VA.
Product codes and lots: Model No. HAA-030-0625-000101; UDI-DI: M572HAA0300625011; Lot No. 1232071.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2405-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2405-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-23	2023-08-16

Product code OQG

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)