Device 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.
Z-2733-2020
Product summary
- Firm
- Arthrex, Inc.
- Event
- Event 86021
- Status
- Terminated
- Classification
- Class II
- Quantity
- 28 units
- Official record key
device-enforcement:Z-2733-2020
Official wording
Reason: Screws provided in packaging are 5mm shorter than intended
Code information: Batch Number: 10706233 UDI Number:00888867056411
Distribution pattern: International distribution in the countries of Denmark, United Kingdom, Sweden, Japan, Netherlands
Derived failure modes
-
Unknown
Screws provided in packaging are 5mm shorter than intended