Ethicon, Inc. Us 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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Ethicon, Inc. Us
Lot Codes / Batch Numbers
UDI-DI: 10705031228061 Lot/Serial No.: B903HPU Expiry Date: 08/21/2026
Products Sold
UDI-DI: 10705031228061 Lot/Serial No.: B903HPU Expiry Date: 08/21/2026
Ethicon, Inc. Us is recalling STRATAFIX SPIRAL PGA-PCL UNI UD 20CM USP2-0(M3) S/A SH. indicated for use in soft tissue approximati due to 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 ta. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026