Recall Z-1676-2020 ยท GFA Blade, Saw, General & Plastic Surgery, Surgical
Synvasive Technology Inc
ZIMMER Oscillating Saw Blade -Cutting 75mm x 19mm x 1.00/1.27mm.intended for bone or cartilage in orthopedic procedures. Manufactured By: Synvasive Technology, Inc., a Subsidiary of Zimmer
| Date | Jul 27, 2018 |
| Status | Terminated |
| Reason | Mislabeled: Actual blade width is 19 mm but the label indicates a width of 25 mm. |
| Root cause | Labeling Change Control |
| Action | Zimmer Biomet issued Urgent Medical Device Recall letter dated 7/27/18 stating reason for recall, health risk and action to take: Review this notification and ensure that affected personnel are aware of the contents. 2. Immediately locate and quarantine affected product in your inventory. 3. Immediately return all affected product from your facility. a. Complete Attachment 1 Inventory Return Certification Form and send to CorporateQuality.PostMarket@zimmerbiomet.com within three (3) days. b. Include a hardcopy of Attachment 1 in each carton of your return shipment for immediate processing. c. |
| Quantity | 266 units |
| Distribution | US distribution to states of AL and NY |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.