Recall Z-0047-2020 ยท NEW Suture, Surgical, Absorbable, Polydioxanone
Ethicon, Inc.
STRATAFIX Spiral PDS Plus Violet 18 (45cm) CT-1 Needle Product code: SXPP1B430 suture
| Date | Oct 4, 2019 (initiated Aug 13, 2019) |
| Status | Terminated |
| 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 |
| Quantity | 416 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 |
| 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 |