The Recall Desk

Manufacturer

Synthes USA HQ, Inc.

56 recalls in our database name Synthes USA HQ, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
56
Critical
0
Severe
4
Most recent
2014-01-08

Of the 56 recalls from Synthes USA HQ, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 4 (7%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

51–56 of 56

  • HighFDA (Devices)·Z-0781-2013·2013-02-13

    Synthes Spine Drill Bit Recalled for Potential Drill Stop Slippage

    Synthes USA is recalling 63 units of 2.5mm drill bits for the Vectra Spine System due to a potential drill stop slippage hazard.

    Product
    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 anterio
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0277-2013·2012-11-21

    Synthes External Fixation Clamp Recalled for Incorrect MR Safety Labeling

    Synthes USA HQ, Inc. is recalling 8 units of External Fixation System Tube to Tube Clamps because the provided insert incorrectly states the product is MR safe, while the device is actually MR Conditional.

    Product
    Synthes External Fixation System Tube to Tube Clamp, Part Number 390.007. Intended for use to provide treatment for long bone and pelvic fractures that require external fixation. Specifically, the components can be used for: Stabilization of soft tissues and fractures; Polytra
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0001-2013·2012-10-10

    Synthes MIRS Spinal Fixation Devices Recalled for Labeling Correction

    Synthes is correcting labeling for MIRS spinal fixation devices to emphasize avoiding rod mis-alignment following reported complaints.

    Product
    MIRS for MATRIX Spine System. Minimally Invasive Reduction Screw (MIRS) for percutaneous instrumentation of the thoracolumbar spine. The Synthes USS are non-cervial spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2206-2012·2012-08-22

    Synthes Hemostatic Bone Putty Recalled for Potential Ignition Risk

    Synthes USA HQ, Inc. is recalling 8,853 packs of Hemostatic Bone Putty because the product may ignite if contacted with electrosurgical cautery systems during surgery.

    Product
    Synthes(R) Hemostatic Bone Putty, Part numbers 08.901.001.97S, 08.901.001.98S, 08.901.001.99S, 08.901.001D, and VB1025.10S. Indicated for use as a water soluble implant material and for use in the control of bleeding from bone surfaces.
    Category
    Medical Device
    Distribution
    27 states
  • ModerateFDA (Devices)·Z-2060-2012·2012-08-01

    Synthes Recalls 4.5mm Multiloc Screws Due to Incorrect Size Labeling

    Synthes USA is recalling two lots of 4.5mm Multiloc Screws because they were incorrectly labeled with the wrong screw size.

    Product
    4.5mm TI Multiloc Screw Length 28MM-Sterile Expiration: 04/29/2012 REF 04.019.028S Manufactured or Distributed by Synthes (USA) 1101 Synthes Avenue, Monument CO 80132 4.5MM TI Multiloc Screw Length 28MM-Sterile Ref 04.019,038S. The Multiloc Screw 4.5 is used with a M
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2059-2012·2012-08-01

    Synthes Recalls 4.5mm Multiloc Screws Due to Incorrect Size Labeling

    Synthes USA is recalling 20 units of 4.5mm Multiloc Screws because they were incorrectly labeled with the wrong screw size.

    Product
    4.5mm TI Multiloc Screw Length 38MM-Sterile Expiration: 04/29/2012 REF 04.019.038S Manufactured or Distributed by Synthes (USA) 1101 Synthes Avenue, Monument CO 80132 4.5MM TI Multiloc Screw Length 38MM-Sterile Ref 04.019,038S. The Multiloc Screw 4.5 is used with a M
    Category
    Medical Device
    Distribution
    Distributed nationwide