Device Recall Zimmer Oscillating Flat 의 리콜

Recall

72811

Class 2

Z-0466-2016

2015-12-08

Terminated

United States

2016-11-01

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142288

Two lots of oscillating saw blades incorrectly identify the blade cutting width as 25mm instead of the correct specification of 19mm.

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.