| Date Initiated by Firm |
December 08, 2015 |
| Create Date |
December 22, 2015 |
| Recall Status1 |
Terminated 3 on November 01, 2016 |
| Recall Number |
Z-0466-2016 |
| Recall Event ID |
72811 |
| Product Classification |
Blade, saw, general & plastic surgery, surgical - Product Code GFA
|
| Product |
Zimmer Oscillating Flat - TS ST Hub;
75mm x 19mm x 1.00/1.27mm;
Synvasive Part No. 11-4770:
Part No. 19075127YT1;
Lot No. 45104 and 43054
Description: STRYK_76542K_19X75X1.27T
General and Plastic Surgery: The oscillating surgical saw blade is intended for use with powered equipment to resect bone and/or cartilage in orthopedic procedures
|
| Code Information |
Synvasive Part number: 11-4770; Part number: 19075127YT1; Lot numbers: 45104 and 43054. |
Recalling Firm/
Manufacturer |
Synvasive Technology Inc
4925 Robert J Mathews Pkwy
El Dorado Hills CA 95762-5701
|
| For Additional Information Contact |
Dona M. Reust
574-372-4316
|
Manufacturer Reason
for Recall |
Two lots of oscillating saw blades incorrectly identify the blade cutting width as 25mm instead of the correct specification of 19mm.
|
FDA Determined
Cause 2 |
Labeling False and Misleading |
| Action |
Zimmer sent an Urgent Medical Device Removal letter on December 10, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Customers were instructed:
I. Review this notification.
2. You will receive copies of notification sent directly to hospital risk managers and surgeons in your territory. As necessary, review and facilitate understanding of this notification by those entities.
3. Further identify hospital risk managers and/or surgeons in your territory who should also receive notification of this update, and supply the information to the entities you have identified.
4. If after reviewing this notification you have further questions or concerns, please call 330-364-0989 between the hours of 8 a.m. and 5 p.m. EST, Monday through Friday.
Letters to Rick Managers are similar and the actions requested by them are:
1. Reviewing this notification and forwarding to all people within your organization that may utilize this product.
2. Identifying and quarantining the affected product to prevent further distribution or use.
3. Completing the attached Response Form and returning it via e-mail to
CorporateQua1ity.PostMarket@zimmerbiomet.com. Returning affected product to:
Zimmer Surgical
Attn: QA!RA Dept. - Recall
Please include a copy of the Response Form with the shipment.
4. Upon receipt of affected product, Zimmer will credit your account for unused Zimmer Oscillating Flat Blade - TS ST Hub, 75mm x 19mm, xl.OO/l.27mm, lots 43054 and 45104 only. Please return a copy of the completed response form along with your returned product to ensure proper credit.
Important: Please distribute this notification to all personnel within your organization who need to be aware. If you have further distributed affected product(s), please provide the customer 's information on the Business Response Form to Zimmer.
Letters also included a FAQ sheet regarding the labeling error. |
| Quantity in Commerce |
14 |
| Distribution |
US Distribution to one location each in CT, MA and CA. |
| Total Product Life Cycle |
TPLC Device Report
|
|
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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