fda
12 records
FDA Recall: Amendia, Inc — Class II
20180117
Incorrect labeling for the lot of MAC Pins. Although the pins are laser as 460 mm in length, the pins are 60 mm in length. | Product: Mac Pin Non-Cannulated Screw, 6.5 x 60mm
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FDA Device Recall: Mac Pin Non-Cannulated Screw, 6.5 x 60mm
2018-01-17
Class II — Incorrect labeling for the lot of MAC Pins. Although the pins are laser as 460 mm in length, the pins are 60 mm in length.
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FDA Device Recall: 01.4mm x 457mm (18in) K-Wire, Threaded Blunt, Ref 9080B-18T, Qty: 1 per pack, M
2017-05-03
Class II — Mislabeled guide wires - It was discovered that some Guide Wires labeled as stainless steel were actually manufactured from nitinol.
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FDA Device Recall: Ceres-C Standalone Cervical Interbody The product is a stand-alone anterior c
2017-01-18
Class II — Absent tantalum market pin.
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FDA Recall: Amendia, Inc — Class II
20161228
The rods are packaged in packages with unacceptable seals. In some cases, the integrity of the seal is compromised by channels or voids. | Product: K-Wire 1.4mm x 12in Non-Threaded, Part Number 9080-...
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FDA Recall: Amendia, Inc — Class II
20161228
There is a problem with the mating feature between the plate and screw which could cause the plate opening not to interfere enough with the plate and | Product: Black Widow 6.6mm x 20mm Screw, Part N...
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FDA Device Recall: K-Wire 1.4mm x 12in Non-Threaded, Part Number 9080-12U; K-Wire Threaded 1.4mm x
2016-12-28
Class II — The rods are packaged in packages with unacceptable seals. In some cases, the integrity of the seal is compromised by channels or voids.
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FDA Device Recall: Black Widow 6.6mm x 20mm Screw, Part Number TBS020; Black Widow 6.6mm x 25mm Scr
2016-12-28
Class II — There is a problem with the mating feature between the plate and screw which could cause the plate opening not to interfere enough with the plate and head of the screw.
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FDA Device Recall: Zeus-P Lumbar Interbody Device
2016-12-28
Class II — Labeling error where three boxes in inventory had conflicting patient and primary labels. Evaluation indicated that the primary label and patient label did not match. The primary label mat...
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FDA Device Recall: Dual Stylet Needle, Part Number 812-11R-15 The guide wire is passed through the
2016-12-28
Class II — The rods are packaged in packages with unacceptable seals. In some cases, the integrity of the seal is compromised by channels or voids.
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FDA Device Recall: Optimus Fixed Awl
2016-12-28
Class II — Complaints that the tip of the awl broke after impaction during surgery.
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FDA Device Recall: Savannah-T Straight Rod, 200mm, Part Number 10704-200; Savannah-T Straight Rod,
2016-12-28
Class II — The rods are packaged in packages with unacceptable seals. In some cases, the integrity of the seal is compromised by channels or voids.
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nppes
1 records
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