Z-0150-2023Class II

STRATAFIX SPIRAL PGA-PCL UNI UD 20CM USP2-0(M3) S/A SH. indicated for use in soft tissue approximation where...

Name: Z-0150-2023 STRATAFIX SPIRAL PGA-PCL UNI UD 20CM USP2-0(M3) S/A SH. indicated for use in soft tissue approximation where...
Creator: Ethicon, Inc.
Published: 2022-09-20
License: https://open.fda.gov/license/

Ethicon, Inc / initiated 2022-09-20 / Open, Classified / root cause: packaging

FDA source

Ethicon, Inc. began a recall of 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... on 2022-09-20. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0150-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-09-20
Posted: 2022-10-31
Recalling firm: Ethicon, Inc
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
Product code: GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
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
Root cause tag: packaging
FDA root cause: Under Investigation by firm
Action: 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
Quantity in commerce: 2,280 eaches
Distribution: International distribution of the country of China.
Product codes and lots: UDI-DI: 10705031228061 Lot/Serial No.: B903HPU Expiry Date: 08/21/2026

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0150-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0150-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-09	2022-10-31

Product code GAM

K151200Class IISTRATAFIX Spiral MONOCRYL Knotless Tissue Control Device, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control DeviceETHICON, Inc. / cleared 2015-08-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)