Device product
STRATAFIX SPIRAL PGA-PCL UNI UD sizes: [20CM USP2-0(M3) S/A RB-1, product code: SXMD1B403-12] and [30CM USP2-0(M3) S/A PS-1, product code: SXMD1B100-12].
Z-1053-2022
Product summary
- Firm
- Ethicon, Inc.
- Event
- Event 90016
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2808 (all OUS)
- Official record key
device-enforcement:Z-1053-2022
Official wording
Reason: Affected product lots may contain the incorrect needle type/size and suture length due to component mix-up.
Code information: Lot AAHM529, UDI(01)10705031228054(20)12(17)260331(10)AAHM529 Lot AAHQ049, UDI (01)10705031228047(20)12(17)260430(10)AAHQ049
Distribution pattern: International distribution in the country of China.
Derived failure modes
-
Unknown
Affected product lots may contain the incorrect needle type/size and suture length due to component mix-up.