The Recall Desk
HighFDA (Devices)·Z-2674-2014·Announced 2014-10-01

DePuy Synthes Recalls TI Vectra Plates Due to Missing Clips

Synthes, Inc. is voluntarily recalling 16 units of TI Vectra Plates because clips may be missing. The plates are used for cervical spine fixation.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a potential defect (missing clips) that could affect the intended function of the device, but the source text does not report any injuries or illnesses, placing it in the 'High' category for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Synthes, Inc. is initiating a voluntary recall of 16 units of DePuy Synthes TI Vectra Plates. These plates are part of the Vectra Anterior Cervical Plate Family of Systems, which are intended for anterior screw fixation to the cervical spine (C2-C7). The recall affects specific lots of the TI Vectra-One Plate 2 Level / 34 mm, TI Vectra Plate 3 Level / 57 mm, and TI Vectra Plate 4 Level / 64 mm.

The recall was initiated because it was discovered that clips are potentially missing from the TI Vectra Plates in certain lots. The affected units were distributed in the United States to the states of Illinois, South Carolina, Virginia, Texas, Massachusetts, North Carolina, Louisiana, California, Alabama, Colorado, Nebraska, Oregon, and Kansas, as well as internationally to Canada.

Healthcare providers and patients should check their inventory or medical records for the specific part and lot numbers listed in the recall notice. If the affected plates are identified, they should be removed from use and returned to Synthes, Inc. according to the company's instructions.

The recalled product

Product
DePuy Synthes TI Vectra Plates: TI Vectra-One" Plate 2 Level / 34 mm part 04.613.184 3337672 TI Vectra" Plate 3 Level / 57 mm part 04.613.257 lot 3693878 TI Vectra" Plate 4 Level / 64 mm part 04.613.364 lot 8143905
Manufacturer
Synthes, Inc.
Affected units
16

Distribution

Distributed in 13 states: