CLASS II Device recall · Reported 24 Aug 2016 · FDA Enforcement Report
TI Single Vector Distractor Body with Left Foot recalled
Synthes (USA) Products is recalling TI Single Vector Distractor Body with Left Foot, distributed nationwide in the US. The recall was initiated on 23 May 2016 and the FDA has classified it as Class II.
Check your package
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-2584-2016
- FDA event ID
- 74419
- Recalling firm
- Synthes (USA) Products, West Chester, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 May 2016
- FDA classified
- 17 Aug 2016
- Reported
- 24 Aug 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 23 May 2016 | Recall initiated by company | |
| 17 Aug 2016 | Classified by FDA | +86 days |
| 24 Aug 2016 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
DePuy Synthes is voluntarily initiating a recall due to a possibility the fastener on the Titanium Single Vector Distractor Body may become prematurely separated from the Proximal Foot Plate.
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
TI Single Vector Distractor Body with Left Foot/30mm; Catalog ID 487.965 The Titanium Single Vector Distractor and Proximal Foot Plates are intended for mandibular bone lengthening where gradual bone distraction is required, including conditions such as congenital mandibular deficiencies or post-traumatic defects.
Where it was distributed
Worldwide Distribution-US (nationwide) distribution to states of: AZ, CA, CO, DC, FL, IL, MA, MI, NJ, NY, PA, TX, UT, WI, and WV; and countries of: Australia, Canada and Switzerland.
Nationwide ArizonaCaliforniaColoradoDistrict of ColumbiaFloridaIllinoisMassachusettsMichiganNew JerseyNew YorkPennsylvaniaTexasUtahWisconsinWest Virginia
Questions about this recall
Is TI Single Vector Distractor Body with Left Foot recalled?
Yes. Synthes (USA) Products recalled TI Single Vector Distractor Body with Left Foot on 23 May 2016. The recall is Class II and its status is Terminated. Recall number Z-2584-2016.
Why was it recalled?
DePuy Synthes is voluntarily initiating a recall due to a possibility the fastener on the Titanium Single Vector Distractor Body may become prematurely separated from the Proximal Foot Plate.
Which lots are affected?
Part # 487.965, Lot # A4JV312; 3959731; 3988317; 4038563; 4091229; 4095071; 4375627; 4375628; 4375629; 4407383; 4420112; 4435710; 4664397; 4664398; 4746860; 5021031; 5143278; 5175697; 5282148; 5321401; 5321402; 5321404; 5332086; 5332087; 5391281; 5391293; 5505151; 5505153; 5559857; 5559858; 5559859; 5621131; 5621132; 5621145; 5621150; 5621166; 5841367; 5857578; 5859707; 5859708; 5859710; 5859711; 6130707; 6130708; 6287524; 6287525; 6538904; 6551654; 6720329; 7458399; 7865439; 9916673; A4JX605, mfg. date 14MAY1999 - 27APR2016, exp. date 24SEP2019-27APR2036
Where was it sold?
Worldwide Distribution-US (nationwide) distribution to states of: AZ, CA, CO, DC, FL, IL, MA, MI, NJ, NY, PA, TX, UT, WI, and WV; and countries of: Australia, Canada and Switzerland.
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.
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