Loading...
Loading...
All product recalls associated with Synthes Spine.
Total Recalls
1000
Past Year
1000
Class I (Serious)
143
Most Recent
Jan 2026
Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.
the dimensional specifications are incorrect
There is a potential for the pump to overinfuse.
the dimensional specifications are incorrect
the dimensional specifications are incorrect
The power manager board may cause a short circuit, resulting in loss of system power, loss of central control monitor or electrical arcing.
the dimensional specifications are incorrect
A change in the software to open up the software architecture to include other analytes other than Estrogen Receptor was made without FDA review and approval.
The recall was initiated after the firm's investigations confirmed that, while lot #186625 passed all internal specifications and quality requirements, the incidence of false positive PCP results has exceeded their post market surveillance thresholds for customer complaints in the field. In addition, the firm has been able to reproduce false positive results reported by customers and as a result
The recall was initiated after Abbott Vascular received reports the protective, yellow balloon sheath of the 4.5mm diameter VOYAGER NC Coronary Dilatation Catheter has been tight. If unnoticed by the user, there is a potential to cause damage to the balloon dilatation catheter during removal of the sheath. The balloon sheath covers the balloon, maintaining the fold configuration and protects the
Software error: The device has a software error that can result in a condition where the displayed image orientation does not match the display orientation markers (right-left reversal).
One of three copper spectral filters could remain within the x-ray while the system displays no spectral filter. The displayed Air Kerma rate and thus cumulative Air Kerma are overestimated. The Air Kerma rate may be over estimated by up to 60%.
The recall involves Krylon "Outdoor Spaces" UV Fabric Protector, which is an aerosol coating used to protect fabric. The part number (#2900) is printed above the UPC (724504029007) on the side of the can. The front of the 11-ounce aerosol can is tan with a picture of a patio containing outdoor furniture. "UV Fabric Protector" and "Outdoor Spaces" are also printed on the front of the can.
GE Healthcare become aware of an incident which caused a slight patient injury during his unload following a prone-oriented scan on Ventri. Although clear safety instructions were not followed in this case, additional measures will be implemented in an effort to reduce the probability or repeat occurrence.
The product is unable to maintain the specification for linearity through the shelf life of the product.
Medtronic has identified an issue related to installation or removal of the Lead Integrity Alert software in EnTrust(R) and EnTrust(R) Escudo" defibrillators. In those devices only, installation or removal of LIA will inadvertently turn off two audible patient alerts.
GE Healthcare has identified a potential pinch point hazard on Ovation MR Scanner when using CTL Array XL Body Flex and Opened Body coil. A patient's hand may be pinched between the magnet bore ceiling cover and the CTL Array, XL Body Flex, or Open Body coil if the patient puts his/her hand on the top of the coil. Two injuries and four complaints filed. 2/20/09: Recall being expanded to incl
GE Healthcare has identified a potential pinch point hazard on Ovation MR Scanner when using CTL Array XL Body Flex and Opened Body coil. A patient's hand may be pinched between the magnet bore ceiling cover and the CTL Array, XL Body Flex, or Open Body coil if the patient puts his/her hand on the top of the coil. 2/20/09: Recall being expanded to include the OpenSpeed Systems.
Alphatec Spine recently discovered that this lot of screws has the incorrect length laser etched on one side of the screw body. As a result, they are conducting a voluntary recall of the Zodiac Titanium cannulated polyaxial screw 6.5 mm x 50 mm L.
The product has the Units of Measure set to mmol/L rather than mg/dL. The blood glucose results could be misinterpreted. This may lead to under treatment and potential for hyperglycemia.
A possible breach of the sterile barrier packaging (Tyvek pouch).