Recall Z-0370-2024— Biomet, Inc.

Name: FDA recall Z-0370-2024
Creator: U.S. Food and Drug Administration
Published: 2023-10-09

Class II · Ongoing

Class II FDA medical device recall by Biomet, Inc., initiated 2023-10-09. It names one FDA 510(k) clearance: K062998. Product: Compress Device Segmental Anchor Plug, 10 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178400. Reason: Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery.

Recalling firm: Biomet, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2023-10-09
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K062998 — COMPRESS SEGMENTAL FEMORAL REPLACEMENT SYSTEM (SHORT SPINDLE AND ANCHOR PLUG)Biomet Manufacturing Corp·cleared 2007-01-19

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

Compress Device Segmental Anchor Plug, 10 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178400

Reason for recall

Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery

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