Recall Z-2423-2016— Biomet 3i, LLC

Name: FDA recall Z-2423-2016
Creator: U.S. Food and Drug Administration
Published: 2015-11-25

Class II · Terminated

Class II FDA medical device recall by Biomet 3i, LLC, initiated 2015-11-25, terminated 2019-07-26. It names one FDA 510(k) clearance: K112730. Product: LDA Screw SBL 4mm(D) Item: SCRSBL2 Dental implants. Reason: Pouches may not have been sealed during packing..

Recalling firm: Biomet 3i, LLC
Classification: Class II
Status: Terminated
Initiated: 2015-11-25
Terminated: 2019-07-26
Firm location: Palm Beach Gardens, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K112730 — ABUTMENT FOR COMPETITIVE IMPLANT STRAUMANN BONE LEVEL CONNECTIONBiomet 3i·cleared 2012-01-13

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

LDA Screw SBL 4mm(D) Item: SCRSBL2 Dental implants

Reason for recall

Pouches may not have been sealed during packing.

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