Class I - Dangerous
There is a potential for the driver to bind up when attempting to advance the intervertebral body fixation screw.
SpineFrontier
33 recalls • • Categories: Infusion Pumps, Surgical Instruments, Other Medical Devices, Implants & Prosthetics
The PedFuse Pedicle Screw Rod Caliper included with the MISquito Pedicle Screw System may be used incorrectly as the Surgical Technique does not adequately convey the intended use of the design.
Class I - Dangerous
A crack may develop in the handle to the Inline Persuader, which may progress if the user continues to use the affected instrument.
It has been verified through field use that there are two possible breakages that may occur when using SI50001 Revision D Lock Shaft Inserter, possibly resulting in instrument fragments entering the sterile field: Impact Cap: The impact cap on the Lock Shaft Inserter can shear off under high-impact force during insertion and removal. Pin: The pin used to guide the Lock Shaft Inserter into the ma
Handles and heads may not be compatible.
Handles and heads may not be compatible.
Handles and heads may not be compatible.
Class I - Dangerous
Bone Probes used to create a pathway in pedicle bone were manufactured and marked to incorrect specifications.
Screw inserters may not mate properly with hex interface of the screws.
Class I - Dangerous
Mismarked and unmarked screws
Class I - Dangerous
Mismarked and unmarked screws
Screw inserters may not mate properly with hex interface of the screws.
Screw inserters may not mate properly with hex interface of the screws.
Class I - Dangerous
Mismarked and unmarked screws
Class I - Dangerous
Mismarked and unmarked screws
During routine servicing, it was discovered that one 8mmx55mm Reset screw was assembled with an 8mm tulip head and a 9mm screw. The implant should have consisted of an 8mm tulip head and an 8mm screw. A recall was initiated to remove all remaining screws of the same lot from the field to investigate the nonconformity.
Fit variation among all lots of S-LIFT extension shims with corresponding retractor blades. The firm's investigation revealed that extension shims may not fit down all retractor blades.
Non-toxic inks, used on the silk screen graphics of the case bases and lids, and caddy lids, were found to be either delaminating or running off from the substrate after repeated washing and sterilization cycles.
Class I - Dangerous
The nipple of the tipped driver broke off when surgeons were attempting to insert the screw.
Device design.
Inserters have a set screw that fixes a collar to the inserter. The screw set can loosen and fall out of the inserter which allows the collar to slide off the proximal end of the inserter. When the collar is not in place the locking sleeve can also slide off the inserter.
Prior to use in surgery, the Drill Guides were presenting noticeable degrees of denting and/or bending. As a result, drills and taps could not be directed down guides during surgery due to mechanical interference.
Difficulty removing screws from the Invue caddies.
During an operation the strike plate of a T-Handle loosened and separated from the T-Handle.
Two sections that are designated for the 8mm and 9mm screws were switched; the holes that hold the 8mm screws are designed for 9mm screws, and the holes that hold the 9mm screws are designated for 8mm screws.
Malfunction of slap hammer.
One of the rods in each of two test constructs did not meet fatigue requirement as outlined in ASTM F1717-04 dynamic compression testing 5 million cycles.
Potential for set screw to be come deformed.
The outer sleeve would not fit over the S-LIFT Inserter assembly because the hole at the top of the sleeve handle was too small.
The S-LIFT Instrument Case contained a bracket with peeling nylon coating.
During two separate occasions an impactor plate on the handle broke off while being struck by a mallet.
When using the optional S-LIFT (also known as S-LIF) Implant Guides without stops, there is a known risk of moving the Implant Guides, and possibly the implant, too far into the disc space creating the potential for injury to the patient. The instructions for Use for the S-Lift Implant Guides will be amended to add the following warning: "Care is to be taken to not over insert the Implant Guides
Inspan Compressors may break at weld causing a loss of compression