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
Recall
- Recall Number
- Z-1676-2020
- Event Number
- 85223
- Firm
- Synvasive Technology Inc
- FEI Number
- 1000123893
- Product Code
- GFA
- Status
- Terminated
- Root Cause
- Labeling Change Control
- Initiated
- July 27, 2018
- Terminated
- June 7, 2021
- Address
- 4925 Robert J Mathews Pkwy, El Dorado Hills, CA, 95762-5701
Description
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
Mislabeled: Actual blade width is 19 mm but the label indicates a width of 25 mm.
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 [email protected] within three (3) days. b. Include a hardcopy of Attachment 1 in each carton of your return shipment for immediate processing. c. Request an RGA number for each unit by calling 800-830-0970 or emailing [email protected]. d. Mark RECALL and RGA Number on the outside of the returned cartons. 4. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facilitys documentation. 5. If you have further questions or concerns after reviewing this notice, please call customer service at 800-830-0970 between 8:00 am and 5:00pm EST, Monday through Friday
US distribution to states of AL and NY
266 units