Recall Z-0159-2021 ยท MAI Fastener, Fixation, Biodegradable, Soft Tissue
Smith & Nephew, Inc.
TWINFIX ULTRA PLLA HA 4.5MM W/ NEEDLES- Absorbable Suture anchor Product Number: 72202612
| Date | Sep 9, 2020 |
| Status | Open, Classified |
| Reason | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch |
| Root cause | Equipment maintenance |
| Action | Smith & Nephew issued Urgent Medical Device Recall letter (R-2020-19) FSN on September 9, 2020 via email or overnight mail to customers that received affected products. Letter states reason for recall, health risk, and action to take: Required Actions: 1. Please inspect your inventory and locate any devices from the listed product and batch numbers enclosed with this Urgent Medical Device Recall Notice, and quarantine them immediately. a. If you are a sales rep or distributor, you must notify your customers of the field action and ensure that the required actions are complete. b. Include the |
| Quantity | 263,874 (total) |
| Distribution | Nationwide Foreign: AE, AT, AU, BE, BM, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DO, EC, EE, ES, FI, FR, GB, GE, GR, HK, HU, IE, IL, IN, IT, JP,KR, LV,MY, NL, NO, PA,PE, PL, PR, PT, RU, SE, SG, SI, TH, TR, TW, UA, & ZA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K151105 | Smith and Nephew Suture Anchors - 5.0mm Absorbable Polymer Anchor, Smith and Nephew Suture Anchors - TAG Bioraptor Sutur Smith & Nephew, Inc., Jul 28, 2015 |