FDASeptember 20, 2022device
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
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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
What to do
FDA enforcement status: Ongoing
Brands named
ethicon
UPCs
10705031228061
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAECHELON LINEAR Cutters Reload 80 mm Blue, intended for transection, resection, and/or creation of anastomoses, Product Number GLC802025-09-11
- FDASTRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device, SFX SPI PDS+ BI VIO 14X14IN(36X36CM) USP1(M4) D/A MO-4. Product Code: SXPP2B400-11.2025-08-15
- FDAEndopath Echelon Vascular White Reload for Advanced Placement Tip (35mm, 4 row); Product code VASECR352025-04-22
- FDAPDSII¿VIO¿30IN(75CM)¿USP6-0(M0.7)¿D/A¿C-12025-03-07
- FDAETHIBOND EXCEL GRN 36IN(90CM) USP2-0(M3) D/A MH2025-03-07
- FDAPROLENE BLU 18IN(45CM) USP6-0(M0.7) S/A P-1 PRM2025-03-07
- FDAPDS¿PLUS¿VIO¿30IN(75CM)¿USP6-0(M0.7)¿D/A¿C-1¿MP2025-03-07
- FDAPROLENE Polypropylene Suture, REF: EH7585H, 8706H, 8833H, 8963H, 8935H PROLENE Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurosurgical procedures.2024-12-20
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