FDAClass IIAugust 23, 2023

Conformis Hip-screw-6.5mm X 25mm recall

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

Why was Conformis Hip-screw-6.5mm X 25mm recalled?

30mm screws were labeled as 25mm screws.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
CONFORMIS HIP-SCREW-6.5MM X 25MM, STERILE EO
Recalling firm
Conformis, Inc.
Quantity
25 units
Distribution
US Nationwide distribution in the states of CA, FL, GA, KS, MA, NV, NY, TN, & VA.
Recall date
August 23, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls