Z-1053-2022Class II

STRATAFIX SPIRAL PGA-PCL UNI UD sizes: [20CM USP2-0(M3) S/A RB-1

Name: Z-1053-2022 STRATAFIX SPIRAL PGA-PCL UNI UD sizes: [20CM USP2-0(M3) S/A RB-1
Creator: Ethicon, Inc.
Published: 2022-03-24
License: https://open.fda.gov/license/

Ethicon, Inc / initiated 2022-03-24 / Open, Classified / root cause: manufacturing process

FDA source

Ethicon, Inc. began a recall of STRATAFIX SPIRAL PGA-PCL UNI UD sizes: [20CM USP2-0(M3) S/A RB-1, product code: SXMD1B403-12] and [30CM USP2-0(M3) S/A PS-1, product code: SXMD1B100-12] on 2022-03-24. FDA classified it as Class II and gives the reason as "Affected product lots may contain the incorrect needle type/size and suture length due to component mix-up". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1053-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-03-24
Posted: 2022-05-10
Recalling firm: Ethicon, Inc
Product: STRATAFIX SPIRAL PGA-PCL UNI UD sizes: [20CM USP2-0(M3) S/A RB-1, product code: SXMD1B403-12] and [30CM USP2-0(M3) S/A PS-1, product code: SXMD1B100-12].
Product code: GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Reason for recall: Affected product lots may contain the incorrect needle type/size and suture length due to component mix-up.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: A translated notification letter was mailed to customers in China on 03/24/2022. Customers are advised to no longer use or distribute recalled product. Arrange returns through your upstream distributor or Johnson & Johnson Medical (Shanghai) Ltd. All customers and sub-distributors are to complete and submit the acknowledgement form. Contact your local sales representative with questions or contact 1-877-ETHICON.
Quantity in commerce: 2808 (all OUS)
Distribution: International distribution in the country of China.
Product codes and lots: Lot AAHM529, UDI(01)10705031228054(20)12(17)260331(10)AAHM529 Lot AAHQ049, UDI (01)10705031228047(20)12(17)260430(10)AAHQ049

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1053-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1053-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-05-18	2022-05-10

Product code GAM

K122898Class IIQuill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corp. Dba Angiotech / cleared 2012-10-22

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)