Recall Z-0626-2024— Encore Medical, LP

Name: FDA recall Z-0626-2024
Creator: U.S. Food and Drug Administration
Published: 2023-10-05

Class II · Completed

Class II FDA medical device recall by Encore Medical, LP, initiated 2023-10-05. It names one FDA 510(k) clearance: K113756. Product: REF 130-03-738, All-Poly e + Patella, Domed Tri-Peg, 9x38mm, STERILE H2O2. Reason: Mislabeling.

Recalling firm: Encore Medical, LP
Classification: Class II
Status: Completed
Initiated: 2023-10-05
Firm location: Austin, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K113756 — HIGHLY CROSS LINKED VE CENTRAL PEG PATELLA HIGHLY CROSS LINKED VE TRI-PEG PATELLA HIGHLY CROSS LINKED VE METAL BACKED PAEncore Medical L.P.·cleared 2012-03-14

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

REF 130-03-738, All-Poly e + Patella, Domed Tri-Peg, 9x38mm, STERILE H2O2

Reason for recall

Mislabeling

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