Hip Screw Labeled as Wrong Size: 30mm Screws Mislabeled as 25mm
Conformis hip screws measuring 30mm have been mislabeled as 25mm, creating risk of incorrect surgical implantation. The recall affects 25 units distributed across nine states.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II recall affecting a surgical implant with a labeling error that could result in improper implantation during surgery. Per the severity rubric, risk-of-harm medical devices where injury has not yet been reported score as High (3).
Plain-English summary
Conformis, Inc. is recalling the CONFORMIS HIP-SCREW-6.5MM X 25MM, STERILE EO. The recalled product consists of hip screws that measure 30mm in length but are labeled as 25mm.
This labeling error creates a risk of confusion during surgical use. Healthcare providers relying on the label during hip implantation procedures could select or install the wrong-sized screw, potentially affecting surgical outcomes and patient safety.
The recall involves 25 units with Lot Number 1232071 (UDI-DI: M572HAA0300625011). Distribution was nationwide across nine states: California, Florida, Georgia, Kansas, Massachusetts, Nevada, New York, Tennessee, and Virginia.
The recalled product
- Product
- CONFORMIS HIP-SCREW-6.5MM X 25MM, STERILE EO
- Manufacturer
- Conformis, Inc.
- Hazard
- Affected units
- 25
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Model No. HAA-030-0625-000101
- UDI-DI: M572HAA0300625011
- Lot No. 1232071.
Distribution
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