Synthes Multi-Vector Distractor Body Recalled for Manufacturing Defect
Synthes USA HQ, Inc. is recalling two units of the Multi-Vector Distractor Body because the sheer pin may not meet product specifications.
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 2/5 (Moderate).
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, and the source text does not report any injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Synthes USA HQ, Inc. is recalling two units of the Synthes Multi-Vector Distractor Body, Part Number 487.931, used for mandibular bone lengthening. The recall was initiated after it was discovered that the sheer pin on the device may not be made according to product specifications.
The affected units were distributed nationwide, including in Colorado, Louisiana, Maryland, Minnesota, New York, Pennsylvania, Rhode Island, Tennessee, Texas, and Utah. The specific part number is 487.831, and the affected lot numbers are 7826459, 7750064, 7667285, and 7806090.
Healthcare providers and patients should contact Synthes USA HQ, Inc. for further instructions regarding the replacement or return of these devices.
The recalled product
- Product
- Synthes Multi-Vector Distractor Body, Part Number 487.931. For mandibular bone lengthening.
- Manufacturer
- Synthes USA HQ, Inc.
- Hazard
- Affected units
- 2
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 (4)
- Part number 487.831 - Lot numbers 7826459
- 7750064
- 7667285
- and 7806090.
Distribution
Part of a larger recall action
This product is one of 3 recalled by Synthes USA HQ, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →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 · manufacturing defect
See all →- HighBeak & Skiff Alcohol Antiseptic Sanitizer recalled for acetaldehyde contamination
FDA (Drugs) · 2026-10-14
- HighFDA Recalls Opportunity Pro Nitrile Gloves Due to Manufacturing Defects
FDA (Devices) · 2026-10-07
- HighWright Medical Recalls Charlotte Claw Screws Due to Missing Threads
FDA (Devices) · 2026-10-07
- ModerateCustom Interventional Pain Management Recalls Mastisol Skin Adhesive Trays
FDA (Devices) · 2026-10-07
- HighNOxBOXi Nitric Oxide Delivery System Recalled for Oxygen Sensor Defect
FDA (Devices) · 2026-10-07
Similar recalls
- ModerateSynthes Recalls Multi Vector Distractor Pin Holding Clamps Due to Binding
FDA (Devices) · 2013-07-24
- HighSynthes Recalls Titanium Single Vector Distractor Bodies Due to Fastener Separation Risk
FDA (Devices) · 2016-08-24
- HighSynthes Titanium Single Vector Distractor Body Recalled for Fastener Separation
FDA (Devices) · 2016-08-24
- HighSynthes Titanium Single Vector Distractor Recalled for Fastener Separation Risk
FDA (Devices) · 2016-08-24
- ModerateSynthes CMF Distraction System Recalled for Misalignment
FDA (Devices) · 2013-07-24
- HighSynthes Recalls Titanium Single Vector Distractor Proximal Foot Plates
FDA (Devices) · 2016-08-24