FDA Medical Device Recalls (openFDA)
Ethicon, Inc.: STRATAFIX Spiral PDS Plus Violet 27 (70cm) CTX Needle Product code: SXPP1B401 suture
- Recall number
- Z-0048-2020
- Recalling firm
- Ethicon, Inc.
- Product
- STRATAFIX Spiral PDS Plus Violet 27 (70cm) CTX Needle Product code: SXPP1B401 suture
- Status
- Terminated
- Initiated
- 2019-08-13
- Posted
- 2019-10-04
- Terminated
- 2021-02-11
- Reason
- The product does not meet certain internal strength testing specifications.
- Root cause
- Under Investigation by firm
- Action
- 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 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 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.
- Quantity
- 852 each
- 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
- Lot, serial or model codes
- Lot # MMH401 GTIN: 10705031236042
- 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