Device Recall Orthopedic Salvage System (OSS) 9cm 의 리콜

Recall

76082

Class 2

Z-1114-2017

2016-12-16

2017-01-28

Terminated

United States

2017-07-21

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152112

Labeling for specific lots of the standard oss modular proximal tibia incorrectly identifies the components as avl modular proximal tibia. the mislabeling could have the potential risks: a delay in surgery less than 30 minutes. patient undergoes a revision with increased risk of infection.

On 12/16/2016 and 12/21/2016, Zimmer Biomet contacted distributors via telephone to notify them of the issue and requested that the product be placed in a quarantine location to prevent use. On 12/22/2016 URGENT MEDICAL DEVICE RECALL REMOVAL- LOT SPECIFIC notifications were sent to the affected distributors and Risk Managers / Surgeons via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Distributor responsibilities include: 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 and surgeons within your territory along with a completed Attachment 1  Inventory Return Certification Form to Zimmer Biomet. a. Request a Return Authorization Number via email to rgarequest@zimmerbiomet.com. Be sure to specify RECALL as the RGA type. b. For each return, send a copy of Attachment 1 to corporatequality.postmarket@zimmerbiomet.com. c. Include a hardcopy of Attachment 1 with your shipment for immediate processing. 5. Note that any hospitals and/or surgeons that received direct shipments of this product from Zimmer Biomet will be sent a copy of the Risk Manager and Surgeon Recall Notice directly. It is important that you review the list of hospitals and/or surgeons included with the email notification sent to your facility to identify additional accounts Zimmer Biomet has not notified. Using the Additional Accounts Form provided with the email notice sent to your facility, return contact information for a