FDA recall Z-2733-2020

Product

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

Distribution

International distribution in the countries of Denmark, United Kingdom, Sweden, Japan, Netherlands

Key facts

Status

Terminated

Initiation date

2020-06-24

Report date

2020-08-05

Termination date

2021-02-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Naples, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2733-2020