STRATAFIX recallZ-1335-2020 · Ethicon, Inc. · initiated Aug 28, 2019
Terminated
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 do not meet certain internal testing specifications.
FDA root cause category: Under Investigation by firm
What the company is doing
On 8/28/2019, Ethicon contacted their international (OUS) customers and shared a copy of the Urgent Medical Device Recall notice issued to U.S. customers. Customers were advised to take the following actions: 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 subject to this recall that are in their inventory immediately. 6. 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-1335-2020
- Status
- Terminated
- Initiated by the company
- Aug 28, 2019
- Posted by the FDA
- Feb 6, 2020
- Recalling firm
- Ethicon, Inc.
- Quantity
- 660 units
- Product code
- NEW
- FDA submissions
- K182873
- Distribution
- International: Australia, Hong King, India, Japan, Korea, Singapore, Thailand
Product description
1 STRATAFIX" Spiral PDS Plus Violet 36" (90cm) CTX Needle, SXPP1B402
Code information (models, lots, serial numbers)
GTIN: 10705031236059 Lot Numbers: PAH073, PAH054 Expiration Date: 12/31/2020
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- STRATAFIX SXPP1B402Ethicon, LLC · SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE1 recall4 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 84772).
- Z-1334-2020 · Terminated1 STRATAFIX Spiral PDS Plus Violet 18" (45cm) OS-6 Needle, SXPP1B201
- Z-1336-2020 · Terminated1 STRATAFIX" Spiral PDS Plus Violet 12" (30 cm) CT-1 Needle, SXPP1B429
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 16, 2026. Text above is shown as published by the FDA.
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