STRATAFIX recallZ-0047-2020 · Ethicon, Inc. · initiated Aug 13, 2019
Class II Terminated All recalls posted in October 2019
Is my device affected?
- 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.
- 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.
- 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
The product does not meet certain internal strength testing specifications.
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-0047-2020
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Aug 13, 2019
- Posted by the FDA
- Oct 4, 2019
- Recalling firm
- Ethicon, Inc.
- Quantity
- 416 each
- Product code
- NEW
- FDA submissions
- K182873
- 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 description
STRATAFIX Spiral PDS Plus Violet 18 (45cm) CT-1 Needle Product code: SXPP1B430 suture
Code information (models, lots, serial numbers)
Lot # LPH946 GTIN: 10705031235823
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- STRATAFIX SXPP1B430Ethicon, LLC · SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE1 recall3 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 83715).
- Z-0048-2020 · TerminatedSTRATAFIX Spiral PDS Plus Violet 27 (70cm) CTX Needle Product code: SXPP1B401 suture
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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