Recall Z-1954-2016— Zimmer Trabecular Metal Technology, Inc.

Name: FDA recall Z-1954-2016
Creator: U.S. Food and Drug Administration
Published: 2016-04-15

Class II · Terminated

Class II FDA medical device recall by Zimmer Trabecular Metal Technology, Inc., initiated 2016-04-15, terminated 2017-11-29. It names 2 FDA 510(k) clearances: K983128, K980486. Product: REV. SHELL LINER 0D 28X48 00700504828 REV. SHELL LINER 10D 28X50 00701005028 REV. SHELL LINER 10D 28X52 00701005228 REV. SHELL LINER 10D 28X54 00701005428 REV. SHELL LINER 10D 28X56 00701005628 REV. SHELL LINER 10D 28X58 00701005828 REV. SHELL LINER 10D 28X60 00701006028 REV. SHELL LINER 10D 28X62 00701006228 REV. SHELL LINE 10D 28X66 00701006628 REV. SHELL LINER 20D 28X48 00702004828 REV. SHELL LINER 20D 28X50 00702005028 REV. SHELL LINER 20D 28X52 00702005228 REV. SHELL LINER 20D 28X54 00702005428 REV. SHELL LINER 20D 28X56 00702005628 REV. SHELL LINER 20D 28X60 00702006028 REV. SHELL LINER 20D 28X62 00702006228 REV. SHELL LINER 20D 28X66 00702006628. Reason: Zimmer Biomet is initiating a recall of specific lots of foil pouched, sterile Trabecular Metal implants that were manufactured between April 2011 and October 2012. The foil pouches are part of a dual barrier system to provide sterile integrity..

Recalling firm: Zimmer Trabecular Metal Technology, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-04-15
Terminated: 2017-11-29
Firm location: Parsippany, NJ, United States

510(k) clearances named in this recall

2 on FDA's record

K983128 — IMPLEX HEDROCEL REPLACEMENT CUP INSERT MODEL NUMBERS 02-246-XXYYY, 02-247-XXYYY, 02-248-XXYYYImplex Corp.·cleared 1998-12-03
K980486 — IMPLEX HEP ACETABULAR REVISION CUP, CEMENTED OR CEMENTLESS MODEL A-240 SYSTEMImplex Corp.·cleared 1998-04-14

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

REV. SHELL LINER 0D 28X48 00700504828 REV. SHELL LINER 10D 28X50 00701005028 REV. SHELL LINER 10D 28X52 00701005228 REV. SHELL LINER 10D 28X54 00701005428 REV. SHELL LINER 10D 28X56 00701005628 REV. SHELL LINER 10D 28X58 00701005828 REV. SHELL LINER 10D 28X60 00701006028 REV. SHELL LINER 10D 28X62 00701006228 REV. SHELL LINE 10D 28X66 00701006628 REV. SHELL LINER 20D 28X48 00702004828 REV. SHELL LINER 20D 28X50 00702005028 REV. SHELL LINER 20D 28X52 00702005228 REV. SHELL LINER 20D 28X54 00702005428 REV. SHELL LINER 20D 28X56 00702005628 REV. SHELL LINER 20D 28X60 00702006028 REV. SHELL LINER 20D 28X62 00702006228 REV. SHELL LINER 20D 28X66 00702006628

Reason for recall

Zimmer Biomet is initiating a recall of specific lots of foil pouched, sterile Trabecular Metal implants that were manufactured between April 2011 and October 2012. The foil pouches are part of a dual barrier system to provide sterile integrity.

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