Terminated

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

FDA Recall Z-1954-2016 · Posted None

Recalling FirmZimmer Trabecular Metal Technology, Inc.

Recall StatusTerminated

Product CodeJDI

Date Initiated2016-04-15

Date Terminated2017-11-29

Product Quantity19,884 total

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.

Firm Action

Zimmer issued an Urgent Medical Device Recall Letter dated 4/15/2016.

Root Cause

Unknown/Undetermined by firm

Distribution Pattern

Nationwide and Foreign.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K983128IMPLEX HEDROCEL REPLACEMENT CUP INSERT MODEL NUMBERS 02-246-XXYYY, 02-247-XXYYY, 02-248-XXYYYImplex Corp. · 1998-12-03 K980486IMPLEX HEP ACETABULAR REVISION CUP, CEMENTED OR CEMENTLESS MODEL A-240 SYSTEMImplex Corp. · 1998-04-14

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.