—#119576

Product

Multi Vector Distractor Pin Holding Clamp, limited bone stock The holding clamp is part of the Multi Vector Distractor which cis used for mandibular bone lengthening, including conditions such as congenital mandibular deficiencies or post-traumatic defects. The Multi Vector Distractor can be utilized to perform bone transport procedures as an alternative to bone grafts and free flaps.

FDA product code: DZL — Screw, Fixation, Intraosseous
Device class: Class 2
Medical specialty: Dental
510(k) numbers: K010690
Affected lot / code info: Titanium Multi Vector Distractor Pin Holding Clamp, body, limited bone stock Part # 487.941 with lot numbers: 3769720, 3779569, 3788731, 3794434, 7806093, 7823463 and Titanium Multi Vector Distractor Pin Holding Clamp, ramus, limited bone stock Part # 487.942 with lot numbers: 3769706, 3779571, 3788741, 7806096, 7823464.

Why it was recalled

Synthes is initiating a voluntary Medical Device removal for specified part numbers and lot numbers of the Mutis Vector Distractor Pin Holding clamp, limited bone stock. The firm received complaints that the clamp and nut construct would not engage the distractor arm threads and subsequently bind. It is not likely that a serious adverse event will result due to a nonconforming clamp, however there

Root cause (FDA determination)

Device Design

Action the firm took

Synthes sent a Urgent Notice: Medical Device Removal letter dated May 31, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. The firm received complaints that the clamp and nut construct would not engage the distractor arm threads and subsequently bind. It is not likely that a serious adverse event will result due to a nonconforming clamp, however, there is a remote potential that additional intervention would be required due to a non-functioning clamp. Synthes requested the product to be removed from inventory and returned to Synthes by calling 1-800-479-6329 to obtain a Return Authorization Number. Direct Accounts were asked to complete and return the Verification Section at the end of the letter indicating the quantity of affected product was found. Negative responses were also requested. If you have any questions please call (610) 719-5450.

Recalling firm

Firm: Synthes USA HQ, Inc.
Address: 1302 Wrights Ln E, West Chester, Pennsylvania 19380-3417

Distribution

Distribution pattern: US Nationwide Distribution including the states of MA, TX, MN, SC, UT, VA, and NY.

Timeline

Recall initiated: 2013-05-31
Posted by FDA: 2013-07-17
Terminated: 2015-08-31
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #119576. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.