FDA Medical Device Recalls (openFDA)
Ethicon, Inc.: 1 STRATAFIX" Spiral PDS Plus Violet 12" (30 cm) CT-1 Needle, SXPP1B429
- Recall number
- Z-1336-2020
- Recalling firm
- Ethicon, Inc.
- Product
- 1 STRATAFIX" Spiral PDS Plus Violet 12" (30 cm) CT-1 Needle, SXPP1B429
- Status
- Terminated
- Initiated
- 2019-08-28
- Posted
- 2020-02-06
- Terminated
- 2021-02-11
- Reason
- The product do not meet certain internal testing specifications.
- Root cause
- Under Investigation by firm
- Action
- 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 Ethicon5647@stericycle.com 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.
- Quantity
- 133 units
- Distribution
- International: Australia, Hong King, India, Japan, Korea, Singapore, Thailand
- Lot, serial or model codes
- GTIN: 10705031235816 Lot Number: PAH166 Expiration Date: 12/31/2020
- 510(k) numbers
- ["K182873"]
- PMA numbers
- not on file
- Product code
- NEW
- Firm FEI
- 2210968
- Firm city
- Somerville
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28