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.
What this means for you
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
Related recalls
Same manufacturer · Conformis, Inc.
See all →- HighConformis Restor3d Cordera Hip Acetabular Liner Mislabeled
FDA (Devices) · 2025-04-23
- HighConformis Identity Imprint PS Tibial Tray Size 4 Packaging Error
FDA (Devices) · 2024-04-24
- HighiTotal Identity Impactor Handle surgical screws may loosen during procedures
FDA (Devices) · 2023-02-22
- HighiTotal Identity Knee Replacement System—incorrect tibial base plate packaged
FDA (Devices) · 2022-04-20
- HighConformis Recalls iTotal Hip Replacement System Due to Incorrect Components
FDA (Devices) · 2020-12-02
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02