Food, drugs, devices › Synthes USA HQ, Inc.
Device recall: Synthes(R) Spine Vectra, Vectra-T and Vectra-One Anterior Cervical Plating for Spinal Fusion - 2.5mm Drill Bit, graduate
FDA enforcement event 62943 is a device recall by Synthes USA HQ, Inc. of West Chester, PA, initiated 6 Aug 2012 and classified Class II, with 2 product records.
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. 88% of the 823 device enforcement events initiated in 2012 carry the same class.
Status: Terminated, terminated 31 Aug 2015. Initiation: voluntary: firm initiated. Synthes USA HQ, Inc. has 51 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 USA HQ, Inc., West Chester, PA.
Reason for recall
"Although the reported incidence is low, there is the potential for the drill stop to slip on the drill bit resulting in an adverse event."
Distribution
"Nationwide Distribution-including Puerto Rico and the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0781-2013 | Synthes(R) Spine Vectra, Vectra-T and Vectra-One Anterior Cervical Plating for Spinal Fusion - 2.5mm Drill Bit, graduated 12mm - 26mm adjustable depth, Part Number 03.613.011. Synthes Vectra System, Synthes Vectra-One System and Synthes Vectra-T System is intended for anterior plate and screw fixation of the cervical… | 63 | Class II | Terminated | 13 Feb 2013 |
| Z-0782-2013 | Synthes(R) Spine Vectra, Vectra-T and Vectra-One Anterior Cervical Plating for Spinal Fusion, Adjustable Drill Stop, Part Number 03.613.012. Synthes Vectra System, Synthes Vectra-One System and Synthes Vectra-T System is intended for anterior plate and screw fixation of the cervical spine (C2-C7). | 48 | Class II | Terminated | 13 Feb 2013 |
Context
Other enforcement events for Synthes USA HQ, Inc.
All 51 events for Synthes USA HQ, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Although the reported incidence is low, there is the potential for the drill stop to slip on the drill bit resulting in an adverse event."
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: "Nationwide Distribution-including Puerto Rico and the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM,…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 31 Aug 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.