Synthes Recalls Four Mis-etched Variable Angle Locking Compression Plates
Synthes USA is recalling four Variable Angle Locking Compression Plates that were incorrectly etched with the wrong part number.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a labeling/etching error without reporting any specific injuries, hospitalizations, or deaths, fitting the criteria for a moderate severity labeling error.
Plain-English summary
Synthes USA HQ, Inc. is recalling four units of the Variable Angle Locking Compression Plate (VA-LCP) Dorsal Distal Radius Plate. The specific units involved are from Lot number 7965181 and were distributed in the states of Indiana, Ohio, Pennsylvania, and Texas.
The recall was initiated because one of the plates was incorrectly etched with Part Number 02.115.431 (110 degree) instead of the correct Part Number 02.115.231 (90 degree). This mislabeling could lead to the use of the wrong implant angle during surgical procedures for dorsally displaced fractures, open joint reconstruction, or corrective osteotomies after distal radius malunion.
Healthcare providers and facilities that have received these specific plates should stop using them and contact Synthes USA for further instructions. Patients who have already had these plates implanted should consult their healthcare provider if they have concerns regarding the part number or angle of the implant.
The recalled product
- Product
- Variable Angle Locking Compression Plate/VA-LCP Dorsal Distal Radius Plate, Part Number 02.115.431. Indicated for: Dorsally displaced fractures, Open joint reconstruction, and Corrective osteotomies after distal radius malunion.
- Manufacturer
- Synthes USA HQ, Inc.
- Hazard
- Affected units
- 4
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 (1)
- Lot number 7965181
Distribution
Related recalls
Same manufacturer · Synthes USA HQ, Inc.
See all →- ModerateSynthes Electric Pen Drive Hand Switch Recalled for Labeling Error
FDA (Devices) · 2014-01-08
- ModerateSynthes Trochanteric Fixation Nail Recalled for Incorrect Packaging Labeling
FDA (Devices) · 2013-12-18
- ModerateSynthes TomoFix Osteotomy System Recalled for Surgical Technique Guide Labeling Error
FDA (Devices) · 2013-12-18
- SevereSynthes Recalls Titanium Trochanteric Fixation Nail Systems Due to Missing Bend
FDA (Devices) · 2013-12-11
- ModerateSynthes Soft Tissue Retractor Recalled for Locking Nut Malfunction
FDA (Devices) · 2013-12-11
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