Recall Z-2582-2016
Synthes (USA) Products LLC · initiated May 23, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: 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
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.
FDA-determined cause: Under Investigation by firm
Action taken
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.
Details
- Recall number
- Z-2582-2016
- Initiated
- May 23, 2016
- Terminated
- December 13, 2016
- Product code
- MQN – External Mandibular Fixator And/Or Distractor
- Quantity
- 182 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.
- Recalling firm
- Synthes (USA) Products LLC, West Chester, PA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2581-2016 Class II | TI Single Vector Distractor Body with Right Foot/20mm; Catalog ID 487.962 The Titanium…DePuy Synthes is voluntarily initiating a recall due to a possibility the fastener on the Titanium Single… | 05/23/2016Terminated |
| Z-2583-2016 Class II | TI Single Vector Distractor Body with Right Foot/30mm; Catalog ID 487.964 The Titanium…DePuy Synthes is voluntarily initiating a recall due to a possibility the fastener on the Titanium Single… | 05/23/2016Terminated |
| Z-2584-2016 Class II | TI Single Vector Distractor Body with Left Foot/30mm; Catalog ID 487.965 The Titanium…DePuy Synthes is voluntarily initiating a recall due to a possibility the fastener on the Titanium Single… | 05/23/2016Terminated |
| Z-2585-2016 Class II | TI Single Vector Distractor Proximal Foot/Right; Catalog ID 487.974 The Titanium Single…DePuy Synthes is voluntarily initiating a recall due to a possibility the fastener on the Titanium Single… | 05/23/2016Terminated |
| Z-2586-2016 Class II | TI Single Vector Distractor Proximal Foot/Left; Catalog ID 487.975 The Titanium Single…DePuy Synthes is voluntarily initiating a recall due to a possibility the fastener on the Titanium Single… | 05/23/2016Terminated |