Recall Z-1334-2020 ยท NEW Suture, Surgical, Absorbable, Polydioxanone
Ethicon, Inc.
1 STRATAFIX Spiral PDS Plus Violet 18" (45cm) OS-6 Needle, SXPP1B201
| Date | Feb 6, 2020 (initiated Aug 28, 2019) |
| Status | Terminated |
| 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 |
| Quantity | 3 units |
| Distribution | International: Australia, Hong King, India, Japan, Korea, Singapore, Thailand |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K182873 | STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral PDS Plus Knotless Tissue Control Devices, ETHICON, Inc., Jan 10, 2019 |