Z-1265-2024 Class II Ongoing
FDA device recall Z-1265-2024 was initiated by Howmedica Osteonics Corp. on Feb 6, 2024 and is designated Class II. Reason for recall: Potential packaging breaches of inner blister and outer sterile blister. The recall status is ongoing. Affected quantity: 24 units (US); 1 unit (OUS).
Recall Details
- Product Type
- Devices
- Report Date
- Mar 13, 2024
- Initiation Date
- Feb 6, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 24 units (US); 1 unit (OUS)
Product Description
NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM
Reason for Recall
Potential packaging breaches of inner blister and outer sterile blister.
Distribution Pattern
Domestic: Nationwide Distribution; Foreign: Australia, Canada, Chile, Colombia, Korea, & Japan.
Code Information
Part No. 5537-G-416-E; GTIN: 07613327287745; Lot No. H21A0K, XY776E; Expiration Date: 10/07/2028.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1265-2024
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026