Phoenix Recon Soft Tissue Sleeve Guide, Surgical, Instrument for the sleeve and Orthopedic Manual Surgical Instruments f

FDA device recall Z-0083-2017 · posted 2016-10-14 · Terminated

Recall details

Recalling firm

Zimmer Biomet, Inc.

Reason for recall

Old revisions and new revisions of the soft tissue sleeve and recon targeting arm are not interchangeable, as the new revision tissue sleeve will not fit into the old revision targeting arm. The old revision tissue sleeve has too much clearance with new revision targeting arm. Risks of encountering the affected product include: the correct instrument may not be readily available for the procedure causing the surgeon to complete the procedure by hand; or a delay in surgery greater than 30 minutes may occur while another Recon Targeting Arm or Recon Soft tissue Sleeve is located or while the surgeon completes the procedure by hand.

Action taken

On 8/9/2016, URGENT MEDICAL DEVICE RECALL REMOVAL notifications were sent to the affected consignees 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. For questions or concerns call the customer call center at 1-800-348-9500 ext 1251 between 8:00 am and 5:00pm EST, Monday through Friday. Alternatively, your questions may be sent by email to CPWARFieldAction@zimmerbiomet.com.

Root cause

Finished device change control

Status

Terminated

Product code

FZX

Quantity affected

31

Distribution

US Nationwide Distribution in the states of: MI, UT, SD, OH, WA, KS, MO, NJ, GA, and TX.

Date initiated

2016-08-09

Date posted

2016-10-14

Date terminated

2017-03-23

Location

Warsaw, IN