Device product
STRATAFIX SPIRAL PGA-PCL UNI UD 20CM USP2-0(M3) S/A SH. indicated for use in soft tissue approximation where the use of absorbable sutures is appropriate. Product No.: SXMD1B405-12
Z-0150-2023
Product summary
- Firm
- Ethicon, Inc.
- Event
- Event 90890
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2,280 eaches
- Official record key
device-enforcement:Z-0150-2023
Official wording
Reason: Packages may contain a PS-1 cutting edge needle and not the intended SH taper point needle may result in more tissue trauma than is anticipated for taper point needles, which may necessitate repair
Code information: UDI-DI: 10705031228061 Lot/Serial No.: B903HPU Expiry Date: 08/21/2026
Distribution pattern: International distribution of the country of China.
Derived failure modes
-
Unknown
Packages may contain a PS-1 cutting edge needle and not the intended SH taper point needle may result in more tissue trauma than is anticipated for taper point needles, which may necessitate repair