TI Single Vector Distractor Body with Left Foot/30mm recall
TI Single Vector Distractor Body with Left Foot/30mm; Catalog ID 487.965 The Titanium Single Vector Distractor and Proximal Foot Plates are intended…
Why was TI Single Vector Distractor Body with Left Foot/30mm 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models 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
- 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…
- Recalling firm
- Synthes (USA) Products LLC
- Quantity
- 259 units
- Distribution
- 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.
- Recall date
- August 24, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)