Synthes (USA) Products LLC: 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.

Agency Publication Date: August 17, 2016

Affected Products

Product: TI Single Vector Distractor Body with Right Foot/20mm; Catalog ID 487.962 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.

Part # 487.962, Lot # A4JY080; 4042146; 4042147; 4365410; 4548558; 4664392; 5041113; 5041114; 5041162; 5071337; 5229307; 5414447; 5414448; 5414449; 5422905; 5621082; 5621083; 5621088; 5696010; 6164423; 6164425; 6164555; 6171239; 6171240; 6397761; 7537258; 7927945, mfg date 09JUN1999 -30JUN2015, exp date 22MAR2020-30JUN2035

Lot Numbers:

A4JY080

Product: TI Single Vector Distractor Body with Left Foot/20mm; Catalog ID 487.963 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.

Part #487.963, Lot # A4JX956; 4038561; 4091230; 4281408; 4294703; 4454536; 4475459; 5041111; 5041112; 5414450; 5414451; 5505099; 5505140; 5621104; 5621108; 5621109; 5621110; 6291848; 6879052; 7626782; 7865438; 9890200; mfg. 09JUN1999 -26APR2016, Exp. 22MAR2020-26APR2036

Lot Numbers:

A4JX956

Product: TI Single Vector Distractor Body with Right Foot/30mm; Catalog ID 487.964 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.

Part #487.964, Lot # A4JV280; 4038562; 4091232; 4095219; 4454474; 4485940; 4538241; 5021030; 5041163; 5051836; 5140379; 5175699; 5292906; 5321397; 5321398; 5321399; 5332085; 5391292; 5505143; 5505144; 5505147; 5559642; 5559649; 5559854; 5559855; 5559856; 5621111; 5621115; 5621126; 5621127; 5621128; 5621130; 5868674; 6250788; 6250789; 6250793; 6397763; 6538895; 6551653; 6720328; 6932326; 7489023; 7489024; 7609552; A4JY067, Mfg date 17MAY1999 - 04SEP2014, Exp. date 22MAR2020-04SEP2034

Lot Numbers:

A4JV280

Product: 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.

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

Lot Numbers:

A4JV312

Product: TI Single Vector Distractor Proximal Foot/Right; Catalog ID 487.974 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.

Part # 487.974, Lot# A4JY041; 3949739; 4038565; 4044599; 4091233; 4600267; 4744818; 4745317; 4873173; 4873174; 5202231; 5202232; 5202233; 5202234; 5298113; 5304974; 5354033; 5469087; 5820678; 5860826; 6044556; 6199927; 6778533; 6877042; 6983832; 7492522; 7880980; 7931712; 9885355, mfg. date 11JUN1999 -21DEC2015, exp. date 20JUL2019-21DEC2035

Lot Numbers:

A4JY041

Product: TI Single Vector Distractor Proximal Foot/Left; Catalog ID 487.975 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.

Part #487.975, Lot# A4JV281; 3959732; 3959733; 4038566; 4044600; 4095085; 4418691; 4479352; 4597089; 4767010; 4851967; 4851968; 5277361; 5346057; 5419963; 5433149; 5445352; 5445632; 5445638; 5785469; 5785471; 5828442; 5828447; 5847302; 5847357; 5883452; 6107608; 6107609; 6107614; 6107615; 6141641; 6141642; 6164420; 6164421; 6819614; 7489031; 7537257; 7865426; 7935481; A4JY058, mfg. date 14MAY1999 - 22APR2015, exp. date 06OCT2019-22APR2035

Lot Numbers:

A4JV281

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 74419

Status: Resolved

Manufacturer: Synthes (USA) Products LLC

Manufactured In: United States

Units Affected: 6 products (90 units; 182 units; 413 units; 259 units; 274 units; 599 units)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

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Affected Products

Lot Numbers:

A4JY080

Lot Numbers:

A4JX956

Lot Numbers:

A4JV280

Lot Numbers:

A4JV312

Lot Numbers:

A4JY041

Lot Numbers:

A4JV281