Recall Z-1692-2020— Encore Medical, LP

Name: FDA recall Z-1692-2020
Creator: U.S. Food and Drug Administration
Published: 2018-07-10

Class II · Ongoing

Class II FDA medical device recall by Encore Medical, LP, initiated 2018-07-10. It names one FDA 510(k) clearance: K120241. Product: djosurgical Linear Neck Trials with Spring Sides, Standard, nonsterile, REF S-200635; and djosurgical Linear Neck Trials with Spring Sides, Lateral, nonsterile, REF S-200636. The firm name on the label is djosurgical, Austin, TX.. Reason: The retaining ring on the neck trials has a potential to fail interoperatively..

Recalling firm: Encore Medical, LP
Classification: Class II
Status: Ongoing
Initiated: 2018-07-10
Firm location: Austin, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K120241 — LINEAR HIP STEM, SIZE 5Encore Medical L.P.·cleared 2012-02-24

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

djosurgical Linear Neck Trials with Spring Sides, Standard, nonsterile, REF S-200635; and djosurgical Linear Neck Trials with Spring Sides, Lateral, nonsterile, REF S-200636. The firm name on the label is djosurgical, Austin, TX.

Reason for recall

The retaining ring on the neck trials has a potential to fail interoperatively.

Data sourced from openFDA. This site is unofficial and independent of the FDA.