Z-2585-2016Class II

TI Single Vector Distractor Proximal Foot/Right; Catalog ID 487.974 The Titanium Single Vector Distractor and...

Name: Z-2585-2016 TI Single Vector Distractor Proximal Foot/Right; Catalog ID 487.974 The Titanium Single Vector Distractor and...
Creator: Synthes (USA) Products LLC
Published: 2016-05-23
License: https://open.fda.gov/license/

Synthes (USA) Products LLC / initiated 2016-05-23 / Terminated

FDA source

Synthes (USA) Products LLC began a recall of TI Single Vector Distractor Proximal Foot/Right; Catalog ID 487.974 The Titanium Single Vector Distractor and Proximal Foot Plates are intended for mandibular... on 2016-05-23. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2585-2016
Classification: Class II
Status: Terminated
Initiated: 2016-05-23
Posted: 2016-08-17
Terminated: 2016-12-13
Recalling firm: Synthes (USA) Products LLC
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.
Product code: MQN External Mandibular Fixator And/Or Distractor
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 root cause: Under Investigation by firm
Action: 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: [email protected]., 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.
Quantity in commerce: 274 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2585-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2581-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-24	2016-08-17
Z-2582-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-24	2016-08-17
Z-2583-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-24	2016-08-17
Z-2584-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-24	2016-08-17
Z-2585-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-24	2016-08-17
Z-2586-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-24	2016-08-17

Product code MQN

K981075Class IISynthes (USA) (Synthes) Single Vector Distractor with Detachable FeetSynthes (Usa) / cleared 1998-06-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)