Recall Z-1533-2024 ยท GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Ethicon, Inc.
STRATAFIX Spiral MONOCRYL Plus Bidirectional Knotless Tissue Control Device: STRATAFIX SPIRAL MONOCRYL PLUS BI UD 12+12IN(30+30CM) USP3-0(M2) D/A PS PRM- Indicated for use in soft tissue approximation where the use of absorbable sutures is appropriate. Product Code: SXMP2B412
| Date | Apr 12, 2024 (initiated Mar 8, 2024) |
| Status | Open, Classified |
| Reason | Degraded and unusable upon removal from the foil pouch due to exposed environmental conditions during transit and storage, compromising sterility |
| Root cause | Under Investigation by firm |
| Action | Ethicon issued Urgent: Medical Device Recall (Removal) Letter to Operating Room Supervisors, Materials Management Personnel, and Chief of Surgery via Third Party on March 8, 2024. Letter states reason for recall, health risk and action to take: 1. Examine your inventory immediately to determine if you have product subject to this recall on hand and quarantine such product(s). If you have product subject to this recall, please maintain a copy of this notice with the quarantined product and keep a copy for your records. 2. Communicate the issue to relevant operating room or materials managemen |
| Quantity | 395 units |
| Distribution | CO GA IA MI NJ NY NY PA SC WI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K192580 | STRATAFIX Spiral Monocryl, Plus Bidirectional Knotless Tissue Control Device ETHICON, Inc., Dec 18, 2019 |