—#147495

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.

FDA product code: MQN — External Mandibular Fixator And/Or Distractor
Device class: Class 2
Medical specialty: Dental
510(k) numbers: K981075
Affected lot / code info: 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

Why it was 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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

The firm, DePuy Synthes, mailed out an "URGENT NOTICE: MEDICAL DEVICE RECALL" letter dated 5/23/2016 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to review your inventory and immediately take the following actions: If you DO have any of the identified devices call DePuy Synthes at 1-800-479-6329 to obtain a Return Authorization (RA) Number, complete the Verification Section (page 3 of the letter) indicating the number of devices that were found and return the Verification Section (page 3 of the letter) with the product to the following: Credit/Returns, DePuy Synthes, 1101 Synthes Avenue, Monument, CO 80132, by fax 844-449-8498 or scan/email: Synthes8096@stericycle.com., and complete the Verification section even if you DO NOT have the identified product. Note: If the Verification Section is answered on behalf of more than one facility and/or individual clearly indicate the name and address of the facility and/or individual. If you have any questions, please call 610-719-5450 or contact your DePuy Synthes Sales Consultant.

Recalling firm

Firm: Synthes (USA) Products LLC
Address: 1301 Goshen Pkwy, West Chester, Pennsylvania 19380-5986

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2016-05-23
Terminated: 2016-12-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #147495. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.