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
- Company
- Ethicon, Inc. Us
- Recall Initiated
- September 20, 2022
- Posted
- October 31, 2022
- Recall Number
- Z-0150-2023
- Quantity
- 2,280 eaches
- Firm Location
- Somerville, NJ
Reason for Recall
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
Distribution
International distribution of the country of China.
Lot / Code Info
UDI-DI: 10705031228061 Lot/Serial No.: B903HPU Expiry Date: 08/21/2026
Root Cause
Under Investigation by firm
Action Taken
Ethicon notified the responsible Johnson & Johnson Affiliates in China who are contacting their impacted primary and secondary consignees and/or end customers. Translated letter dated 9/23/22. Customers are requested to return all unused impacted products that are in their inventory immediately. Returned products pertaining to this action will be segregated and destroyed by affiliates per local procedures and regulations