Z-1533-2024Class II

STRATAFIX Spiral MONOCRYL Plus Bidirectional Knotless Tissue Control Device: STRATAFIX SPIRAL MONOCRYL PLUS...

Name: Z-1533-2024 STRATAFIX Spiral MONOCRYL Plus Bidirectional Knotless Tissue Control Device: STRATAFIX SPIRAL MONOCRYL PLUS...
Creator: Ethicon, Inc.
Published: 2024-03-08
License: https://open.fda.gov/license/

Ethicon, Inc / initiated 2024-03-08 / Open, Classified / root cause: packaging

FDA source

Ethicon, Inc. began a recall of STRATAFIX Spiral MONOCRYL Plus Bidirectional Knotless Tissue Control Device: STRATAFIX SPIRAL MONOCRYL PLUS BI UD 12+12IN(30+30CM) USP3-0(M2) D/A PS PRM-... on 2024-03-08. FDA classified it as Class II and gives the reason as "Degraded and unusable upon removal from the foil pouch due to exposed environmental conditions during transit and storage, compromising sterility". 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-1533-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-03-08
Posted: 2024-04-12
Recalling firm: Ethicon, Inc
Product: STRATAFIX Spiral MONOCRYL Plus Bidirectional Knotless Tissue Control Device: STRATAFIX SPIRAL MONOCRYL PLUS BI UD 12+12IN(30+30CM) USP3-0(M2) D/A PS PRM- Indicated for use in soft tissue approximation where the use of absorbable sutures is appropriate. Product Code: SXMP2B412
Product code: GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Reason for recall: Degraded and unusable upon removal from the foil pouch due to exposed environmental conditions during transit and storage, compromising sterility
Root cause tag: packaging
FDA root cause: Under Investigation by firm
Action: Ethicon issued Urgent: Medical Device Recall (Removal) Letter to Operating Room Supervisors, Materials Management Personnel, and Chief of Surgery via Third Party on March 8, 2024. Letter states reason for recall, health risk and action to take: 1. Examine your inventory immediately to determine if you have product subject to this recall on hand and quarantine such product(s). If you have product subject to this recall, please maintain a copy of this notice with the quarantined product and keep a copy for your records. 2. Communicate the issue to relevant operating room or materials management personnel, or anyone else in your facility who needs to be informed. If any product subject to this recall has been forwarded to another facility, contact that facility to arrange return. Please consider including a copy of this recall letter when communicating. 3. Complete the Business Reply Form (BRF) (Attachment 3) confirming receipt of this notice and fax or email to Sedgwick at 855-207-2785 or [email protected] within three (3) business days. Please return the BRF even if you do not have product subject to this recall. 4. Customers are required to return unused STRATAFIX" Spiral MONOCRYL" Plus Sutures subject to this recall that are in inventory immediately. To receive credit, customers must return product subject to this recall no later than June 30, 2024. Any non-affected product and any product returned after the date specified will not receive credit. 5. To return product subject to this recall, photocopy the completed BRF, place it in the box with the product, and affix the pre-paid authorized shipping label included with the recall notification letter. Ethicon will pay for the shipping charges only if the authorized label is used. Extra shipping labels may be obtained by calling Sedgwick at 855-215-5702. Your account number and mailing address have been pre-populated on the BRF. 6. Keep this notice visibly posted for awareness until all product subject to t
Quantity in commerce: 395 units
Distribution: CO GA IA MI NJ NY NY PA SC WI
Product codes and lots: UDI/GTIN: 30705031464289 (box) 10705031464285 (pouch) Lot Number: SHBAEC Exp. Date: June 30, 2024

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1533-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1533-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-04-24	2024-04-12

Product code GAM

K192580Class IISTRATAFIX Spiral Monocryl, Plus Bidirectional Knotless Tissue Control DeviceETHICON, Inc. / cleared 2019-12-18

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)