Device Recall Vanguard Knee System 의 리콜

Recall

80172

Class 2

Z-2183-2018

2018-05-11

2018-06-01

Open, Classified

United States

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=164769

The label master file was errantly set up as a 63/37mm instead of a 63/67mm. there is no 63/37 size offered, and the product is laser marked with the correct size.

The firm, Zimmer Biomet, sent an "Urgent Medical Device Recall (Removal)" letters dated 5/11/2018 to customers on 5/11/18. The letters described the product, problem and actions to be taken. The letters instruct customers to perform the following actions: 1. Review this notification and ensure affected team members are aware of the contents. 2. Immediately locate and quarantine affected product in your inventory. 3. Complete the Certification of Acknowledgement portion of Attachment 1  Inventory Return Certification Form. a. Return a digital copy to corporatequality.postmarket@zimmerbiomet.com within three (3) days. 4. Immediately return all affected product from your distributorship and affected hospitals within your territory along with a completed Attachment 1  Inventory Return Certification Form to Zimmer Biomet. a. For each return, send a copy of Attachment 1 to corporatequality.postmarket@zimmerbiomet.com. b. Include a hardcopy of Attachment 1 with your shipment for immediate processing. c. Mark the outside of the returning product box(es) clearly with RECALL. 5. Distributors will notify their accounts to which the product was further distributed and to locate and return products from these accounts in accordance with local regulations. 6. Retain a copy of your field action acknowledgement and product return forms for your records in the event of a compliance audit of your facility. 7. If after reviewing this notice you have further questions or concerns please call the customer call center at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a voice mail prompt or be transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to CorporateQuality.PostMarket@zimmerbiomet.com.