| Date Initiated by Firm | July 27, 2018 |
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| Create Date | April 06, 2020 |
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| Recall Status1 |
Terminated 3 on June 07, 2021 |
| Recall Number | Z-1676-2020 |
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| Recall Event ID |
85223 |
| Product Classification |
Blade, saw, general & plastic surgery, surgical - Product Code GFA
|
| Product | 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 |
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| Code Information |
Lot Number/UDI: 265474 (01)00846795028320(17)220414(10)265474 304117 (01)00846795028320(17)230131(10)304117 317918 (01)00846795028320(17)230531(10)317918 |
Recalling Firm/
Manufacturer |
Synvasive Technology Inc
4925 Robert J Mathews Pkwy
El Dorado Hills CA 95762-5701
|
| For Additional Information Contact | 411 Technical Services
574-371-3071 |
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Manufacturer Reason
for Recall | Mislabeled: Actual blade width is 19 mm but the label indicates a width of 25 mm. |
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FDA Determined
Cause 2 | Labeling Change Control |
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| 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. Request an RGA number for each unit by calling 800-830-0970 or emailing dover.repairs@zimmerbiomet.com.
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 |
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| Quantity in Commerce | 266 units |
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| Distribution | US distribution to states of AL and NY |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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