Z-1101-2023 Class II Ongoing
FDA device recall Z-1101-2023 was initiated by TriMed Inc. on Dec 22, 2022 and is designated Class II. Reason for recall: Overly aggressive tension on the pull suture, while passing the medial button through a bone/soft tissue tunnel across the fibula and tibia, can exceed its strength causing it to break. The recall status is ongoing. Affected quantity: 76.
Recall Details
- Product Type
- Devices
- Report Date
- Feb 15, 2023
- Initiation Date
- Dec 22, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 76
Product Description
RipCord Syndesmosis Button, REF: STA001K
Reason for Recall
Overly aggressive tension on the pull suture, while passing the medial button through a bone/soft tissue tunnel across the fibula and tibia, can exceed its strength causing it to break.
Distribution Pattern
US Nationwide distribution in the states of IL, PA, TX, GA, TN, AL, MO, FL, AR, LA, HI, OH, TX, KS
Code Information
UDI-DI: 00842188123849, Lot: 85305-01
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1101-2023
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026