Sterile 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.
Reported: August 5, 2020 Initiated: June 24, 2020 #Z-2733-2020
Product Description
Sterile 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.
Reason for Recall
Screws provided in packaging are 5mm shorter than intended
Details
- Recalling Firm
- Arthrex, Inc.
- Units Affected
- 28 units
- Distribution
- International distribution in the countries of Denmark, United Kingdom, Sweden, Japan, Netherlands
- Location
- Naples, FL
Frequently Asked Questions
What product was recalled? ▼
Sterile 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.. Recalled by Arthrex, Inc.. Units affected: 28 units.
Why was this product recalled? ▼
Screws provided in packaging are 5mm shorter than intended
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 5, 2020. Severity: Moderate. Recall number: Z-2733-2020.
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