Z-1045-2023 Class II Ongoing
FDA device recall Z-1045-2023 was initiated by MEDLINE INDUSTRIES, LP - Northfield on Dec 22, 2022 and is designated Class II. Reason for recall: The recall is due to observed intra-operative screw failure. When pre-drilled with ¿1.3mm drill bit for ¿2.0mm screws and ¿1.6mm drill bit for ¿2.4mm we have observed screw failure due to excessive… The recall status is ongoing. Affected quantity: 420 units.
Recall Details
- Product Type
- Devices
- Report Date
- Feb 8, 2023
- Initiation Date
- Dec 22, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 420 units
Product Description
MEDLINE UNITE FOOT & ANKLE Screw, Non-Locking, Mini T8 (2.0x8mm), REF MMSN2008
Reason for Recall
The recall is due to observed intra-operative screw failure. When pre-drilled with ¿1.3mm drill bit for ¿2.0mm screws and ¿1.6mm drill bit for ¿2.4mm we have observed screw failure due to excessive torque.
Distribution Pattern
US Nationwide distribution.
Code Information
GTIN 10193489120387, Lot Number 810304
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1045-2023
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026