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STRATAFIX recallZ-1533-2024 · Ethicon, Inc. · initiated Mar 8, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Ethicon, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Degraded and unusable upon removal from the foil pouch due to exposed environmental conditions during transit and storage, compromising sterility

FDA root cause category: Under Investigation by firm

What the company is doing

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

Recall details

Recall number
Z-1533-2024
Status
Open, Classified
Initiated by the company
Mar 8, 2024
Posted by the FDA
Apr 12, 2024
Recalling firm
Ethicon, Inc.
Quantity
395 units
Product code
GAM
FDA submissions
K192580
Distribution
CO GA IA MI NJ NY NY PA SC WI

Product description

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

Code information (models, lots, serial numbers)

UDI/GTIN: 30705031464289 (box) 10705031464285 (pouch) Lot Number: SHBAEC Exp. Date: June 30, 2024

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

11 devices cleared under K192580 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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