RecallRadar

FDA Device recall Z-2405-2023

CONFORMIS HIP-SCREW-6.5MM X 25MM, STERILE EO

On 2023-08-23 the FDA classified a Class II recall of CONFORMIS HIP-SCREW-6.5MM X 25MM, STERILE EO by Conformis, citing 30mm screws were labeled as 25mm screws.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2405-2023
ClassificationClass II
Statusongoing
Initiated2023-06-16
Published2023-08-23
Last updated2026-09-13 11:56 UTC
CompanyConformis
DistributionUS

Product

CONFORMIS HIP-SCREW-6.5MM X 25MM, STERILE EO

Reason

30mm screws were labeled as 25mm screws.

Identifiers

code_infoModel No. HAA-030-0625-000101; UDI-DI: M572HAA0300625011; Lot No. 1232071.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2405-2023%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.