Z-1259-2024 Class II Ongoing
FDA device recall Z-1259-2024 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: 132 units (US); 26 units (OUS).
Recall Details
- Product Type
- Devices
- Report Date
- Mar 13, 2024
- Initiation Date
- Feb 6, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 132 units (US); 26 units (OUS)
Product Description
X3 TRIATHLON CS INSERT NO 3 10 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. 5531-G-310-E; GTIN: 07613327390544; Lot No. 313JA9, 8711AV, A4462V, XD1AT4, MR77W5, TD5KL3, H97AME, YW30KL; 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-1259-2024
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026