Device product
X3 TRIATHLON CS INSERT NO 3 10 MM
Z-1259-2024
Product summary
- Event
- Event 94026
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 132 units (US); 26 units (OUS)
- Official record key
device-enforcement:Z-1259-2024
Official wording
Reason: Potential packaging breaches of inner blister and outer sterile blister.
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.
Distribution pattern: Domestic: Nationwide Distribution; Foreign: Australia, Canada, Chile, Colombia, Korea, & Japan.
Derived failure modes
-
Unknown
Potential packaging breaches of inner blister and outer sterile blister.