FDAOctober 1, 2019device
Low Profile Screw, 4.5 x 20 mm The Low Profile ScrewTM, 4.5 x 20 mm, AR-8545-20, is used with the Ankle Fusion Line of plates and is intended to provide internal unicortical or bicortical bone fixation.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Screws provided in the device package are 6 mm longer than intended.
What to do
FDA enforcement status: Terminated
Brands named
arthrex
UPCs
00888867124424
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDASmall Joint OATS Set, REF AR-8981-06S, 6mm; and Small Joint OATS Set, REF AR-8981-08S, 8mm, both containing a cannulated reamer, sterile.2022-11-02
- FDAK-Wire, 1.35 mm x 170 mm2022-03-25
- FDASuture Anchor, BioComposite SwiveLock C, 5.5 mm x 19.1 mm, Closed Eyelet, REF AR-2323BCC2021-06-14
- FDATibial Opening Wedge Osteotomy Plate, Titanium, 15.0 mm - Product Usage: use in treatment of non-union, mal-union, and fractures of the proximal tibia and distal femur.2021-03-11
- FDADrill Bit, Cannulated, 5.0 mm - Product Usage: may be used in a variety of foot and ankle procedures.2021-02-24
- FDASterile Low Profile Screw, Titanium, 6.7 x 65mm Part Number: AR-8967-2865S - Product Usage: is intended to be used as a stand-alone bone screw, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions.2020-06-24
- FDAArthrex Fibulock Fibular Nail Instrument Set Reusable non-sterile instruments Outrigger Targeting Guide2019-12-17
- FDAArthrex Burr, Oval, 12 Flute, 5.5 mm x 13 cm (AR-8550OBT) These devices are indicated for resection of soft and osseous tissues in both large and small articular cavities during arthroscopic procedures.2019-01-14
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