Recalls / —

—#161740

Product

JUGGERKNOT 2.9MM 2 #2 MB Product Usage: For use in hip arthroplasty

FDA product code

LZO — Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Device class

Class 2

Medical specialty

Orthopedic

510(k) numbers

K131684

Affected lot / code info

Part number: 912050 Lot number: 221890

Why it was recalled

For soft tissue fixation

Root cause (FDA determination)

Packaging process control

Action the firm took

On June 2, 2017 an URGENT Medical Recall Letter was issued to customers regarding affected product(s). The letter requests customers to review the content and notify affected personnel of the recall. Assist the sales representative in quarantining affected product, which will be removed and returned to recalling firm and then replaced. All customers who may have received product from distributors are to be notified. Questions or concerns can be directed to 1-574-372-4847.

Recalling firm

Firm

Zimmer Biomet, Inc.

Address

56 E Bell Dr, Warsaw, Indiana 46582-6989

Distribution

Distribution pattern

US in the state of Texas

Timeline

Recall initiated

2017-06-30

Terminated

2018-04-13

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #161740. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.