Plate, Bone

ProPlan CMF Patient-Specific Guide, Mandible guides (3A & 3B)-Intended to guide the marking of bone and/or guide surgical instruments in mandibular and maxillof

Wrong versions of guides 3A and 3B (Patient Specific) were shipped prior to the re-design request

Sterile Trac System Thinflap 24 MM Burr Hole Plate, Item number SP-STA-1021-12 - Product Usage: Fixation of Cranial bone

Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.

Lactosorb RapidFlap, bone plate, Model No. 915-0020

The recalling firm has confirmed that the Outer Plate component exhibits an excessive chamfer on the threading after deburring operations. This excessive chamfer results in non-conforming product where the threads of the outer plate component have limited to no engagement with the post component.

1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 24 mm - Sterile, Rapid Resorbable Fixation System. 1.5 mm Rapid Resorbable Orbital Floor Plate with Bend

Labeling errors. The outer packge label expiration date may exceed the expiration date of the subcomponents.

1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 30 mm - Sterile, Rapid Resorbable Fixation System. 1.5 mm Rapid Resorbable Orbital Floor Plate with Bendin

Labeling errors. The outer packge label expiration date may exceed the expiration date of the subcomponents.

1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 35 mm - Sterile, Rapid Resorbable Fixation System. 1.5 mm Rapid Resorbable Orbital Floor Plate with Bendin

Labeling errors. The outer packge label expiration date may exceed the expiration date of the subcomponents.

Synthes TI Matrix Pre-Bent Maxillary Plate / 2mm ADVMNT/0.8mm THK/L and Synthes TI Matrix Pre-Bent Maxillary Plate / 2mm ADVMNT/0.8mm THK/R. The Synthes Matrix

The affected part and lot numbers of the TI Matrix Pre-Bent Maxillary Plates may potentially have the incorrect laser etch denoting the orientation.

Synthes Titanium Midface Distractor, MR Conditional, Part number 487.982. For temporary stabilization and gradual lengthening of the cranial or midfacial bones

There is the potential for the anterior footplates to not fit onto the Titanium Midface Distractor Assembly as the tab of some distractors may be oversized.

Product is labeled in part: "***REF: 01-7036, LOT 999999, "1.5MM" SYSTEM PLATE L-SHAPE, 3 X 3 HOLE, 100 DEGREE, QTY 00001, CE 0086, 2010-04 *** NON-STERILE PR

On 4/26/10 Biomet Microfixation, Jacksonville, FL initiated a recall of their 1.5 3/3 hole 100 degree left X-long L plate, Model #01-7036, Lot #193690. Product is labeled incorrectly.

Product is 40mm Flexible Tube. ***NON-STERILE PRODUCT***CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN."

Lorenz Engineer discovered flex tube could break if bent too much.