Z-0048-2020Class II

STRATAFIX Spiral PDS Plus Violet 27 (70cm) CTX Needle

Name: Z-0048-2020 STRATAFIX Spiral PDS Plus Violet 27 (70cm) CTX Needle
Creator: Ethicon, Inc.
Published: 2019-08-13
License: https://open.fda.gov/license/

Ethicon, Inc / initiated 2019-08-13 / Terminated

FDA source

Ethicon, Inc. began a recall of STRATAFIX Spiral PDS Plus Violet 27 (70cm) CTX Needle Product code: SXPP1B401 suture on 2019-08-13. FDA classified it as Class II and gives the reason as "The product does not meet certain internal strength testing specifications". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0048-2020
Classification: Class II
Status: Terminated
Initiated: 2019-08-13
Posted: 2019-10-04
Terminated: 2021-02-11
Recalling firm: Ethicon, Inc
Product: STRATAFIX Spiral PDS Plus Violet 27 (70cm) CTX Needle Product code: SXPP1B401 suture
Product code: NEW Suture, Surgical, Absorbable, Polydioxanone
Reason for recall: The product does not meet certain internal strength testing specifications.
FDA root cause: Under Investigation by firm
Action: Ethicon sent a letter on 8/30/2019. 1. Examine your inventory quarantine the recalled product 2. Do not open the foil pouches to conform contents 3. Complete the Business Reply Form (BRF)confirming receipt of this notice and fax or email it to Stericycle at 888-877-7241 or [email protected] within three (3) business days. 4. Keep this notice visibly posted for awareness until all product subject to this recall has been returned to Stericycle 5. Distributors are required to return unused impacted STRATAFIX" Spiral PDS" Plus Knotless Tissue Control Devices subject to this recall that are in their inventory immediately. To receive replacement product, customers must return product subject to this recall by November 30, 2019. Any non-affected product or impacted product returned after the date specified will not be replaced. If you require any assistance with returning product, please contact Stericycle at 888-759-6910 and reference Event# 5647. If you have additional questions regarding this recall or to report any customer complaints, please contact Ethicon Customer Support Center at 1-877-ETHICON (1-877-384-4266). The Customer Support Center is open Monday through Friday, 8:00 AM to 6:00 PM ET.
Quantity in commerce: 852 each
Distribution: States: IN MD AR IL GA TN NJ PA NC CA OK CO KS UT KY WA OH OR OUS: Australia Hong King India Japan Korea Singapore Thailand United States
Product codes and lots: Lot # MMH401 GTIN: 10705031236042

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0048-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0047-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-16	2019-10-04
Z-0048-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-16	2019-10-04

Product code NEW

K182873Class IISTRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Knotless Tissue Control DevicesETHICON, Inc. / cleared 2019-01-10

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)