CLASS II Device recall · Reported 13 Mar 2013 · FDA Enforcement Report

Synthes Multi-Vector Distractor recalled by Synthes USA HQ

Synthes USA HQ is recalling Synthes Multi-Vector Distractor, Multi-axial Mandible Distractor (Right), distributed nationwide in the US. The recall was initiated on 11 Jan 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesPart number 487.966 - Lot numbers 7823465, 3817114, 7806086, 3824427, 3808871, 3794465, and 7793336.

Quantity recalled24

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0904-2013
FDA event ID: 64195
Recalling firm: Synthes USA HQ, West Chester, PA
Classification: Class II
Status: Terminated
Recall initiated: 11 Jan 2013
FDA classified: 1 Mar 2013
Reported: 13 Mar 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

11 Jan 2013	Recall initiated by company
1 Mar 2013	Classified by FDA	+49 days
13 Mar 2013	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

It was discovered that the sheer pin on the Multi-Vector Distractor may not be made according to product specifications.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Synthes Multi-Vector Distractor, Multi-axial Mandible Distractor (Right), Part Number 487.966. For mandibular bone lengthening.

Where it was distributed

Nationwide Distribution-including the states of CO, LA, MD, MN, NY, PA, RI, TN, TX and UT.

Nationwide Colorado Louisiana Maryland Minnesota New York Pennsylvania Rhode Island Tennessee Texas Utah

Questions about this recall

Is Synthes Multi-Vector Distractor, Multi-axial Mandible Distractor (Right) recalled?

Yes. Synthes USA HQ recalled Synthes Multi-Vector Distractor, Multi-axial Mandible Distractor (Right) on 11 Jan 2013. The recall is Class II and its status is Terminated. Recall number Z-0904-2013.

Why was it recalled?

It was discovered that the sheer pin on the Multi-Vector Distractor may not be made according to product specifications.

Which lots are affected?

Part number 487.966 - Lot numbers 7823465, 3817114, 7806086, 3824427, 3808871, 3794465, and 7793336.

Where was it sold?

Nationwide Distribution-including the states of CO, LA, MD, MN, NY, PA, RI, TN, TX and UT.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Synthes USA HQ

All 56

Reported	Class	Recall	Company	Reason	Where
8 Jan 2014Device	CLASS II	Synthes Hand Switch - Electric Pen Drive recalled by Synthes USA HQ	Synthes USA HQ	Foreign Material	Nationwide
18 Dec 2013Device	CLASS II	Synthes TomoFix Plates The Synthes J5606-C TomoFix recalled	Synthes USA HQ	Other	Nationwide
18 Dec 2013Device	CLASS II	Synthes Trochanteric Fixation Nail As part of the Synthes recalled	Synthes USA HQ	Labeling Errors	Nationwide
11 Dec 2013Device	CLASS II	Synthes Soft Tissue Retractor Small Extendible recalled	Synthes USA HQ	Device Malfunction	Nationwide
11 Dec 2013Device	CLASS II	Titanium Trochanteric Fixation Nail recalled by Synthes USA HQ	Synthes USA HQ	Other	Nationwide

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