Device product
X3 TRIATHLON CS INSERT NO 6 10 MM
Z-1260-2024
Product summary
- Event
- Event 94026
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 143 units (US)
- Official record key
device-enforcement:Z-1260-2024
Official wording
Reason: Potential packaging breaches of inner blister and outer sterile blister.
Code information: Part No. 5531-G-610-E; GTIN: 07613327390575; Lot No. 1L0WAY, 323EAY, A72D9D, 9885E1, 9Y397R, L573YP; 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.