Food, drugs, devices › Synthes, Inc.
Device recall: DePuy Synthes TI Vectra Plates: TI Vectra-One" Plate 2 Level / 34 mm part 04.613.184 3337672 TI Vectra" Plate 3 Level /
Synthes, Inc. (West Chester, PA) initiated this device recall on 2 Sep 2014; FDA lists 1 product record under event 69178, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,176 device enforcement events initiated in 2014 carry the same class.
Status: Terminated, terminated 2 Sep 2015. Initiation: voluntary: firm initiated. Synthes, Inc. has 39 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Synthes, Inc., West Chester, PA.
Reason for recall
"DePuy Synthes is initiating a voluntary medical device recall of certain lots of the TI Vectra Plates, which is a part of the DePuy Synthes Vectra Anterior Cervical Plate Family of Systems. The Vectra Systems are intended for anterior screw fixation to the cervical spine (C2-C7). It was discovered in certain lots, that the clips are potentially missing from the TI Vectra Plates resulting in the i"
Distribution
"US Distribution including the states of IL, SC, VA, TX, MA, NC, LA, CA, AL, CO, NE, OR and KS., and Internationally to Canada."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2674-2014 | 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 | 16 | Class II | Terminated | 1 Oct 2014 |
Context
Other enforcement events for Synthes, Inc.
All 39 events for Synthes, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "DePuy Synthes is initiating a voluntary medical device recall of certain lots of the TI Vectra Plates, which is a part of the DePuy Synthes Vectra Anterior Cervical Plate Family of Systems. The Vectra Systems are intended for anterior screw fixation to the cervical spine (C2-C7). It was discovered in certain lots, that the clips are potentially missing from the TI Vectra Plates resulting in the i"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US Distribution including the states of IL, SC, VA, TX, MA, NC, LA, CA, AL, CO, NE, OR and KS., and Internationally to Canada."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 2 Sep 2015. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.