Recall Z-0843-2024— FX SHOULDER

Name: FDA recall Z-0843-2024
Creator: U.S. Food and Drug Administration
Published: 2023-08-08

Class II · Ongoing

Class II FDA medical device recall by FX SHOULDER, initiated 2023-08-08. It names one FDA 510(k) clearance: K191146. Product: Centered Glenosphere w/Screw, CoCr/TA6V/TiN 10-degrees Tilt 32 mm, REF: 115-3210. Reason: Centered glenosphere box may contain an eccentric glenosphere..

Recalling firm: FX SHOULDER
Classification: Class II
Status: Ongoing
Initiated: 2023-08-08
Firm location: Dallas, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K191146 — Humelock TiN Coated GlenosphereFx Shoulder USA, Inc.·cleared 2020-07-15

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

Centered Glenosphere w/Screw, CoCr/TA6V/TiN 10-degrees Tilt 32 mm, REF: 115-3210

Reason for recall

Centered glenosphere box may contain an eccentric glenosphere.

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