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 0
Check against the official notice below — it lists the full affected range.
Zimmer Biomet is recalling specific lots of sterile Trabecular Metal implants manufactured between April 2011 and October 2012. The implants come in foil pouches that are designed to maintain sterile integrity as part of a dual barrier system. A total of 19,884 units have been distributed nationwide and to foreign locations across multiple product codes and lot numbers.
The record does not specify a remedy for consumers affected by this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. Distribution: Nationwide and Foreign. Quantity: 19,884 total Lot/code info: 00700504828 REV. SHELL LINER 0D 28X48 62192382 61924517 61979224 62102328 00701005028 REV. SHELL LINER 10D 28X50 61787378 61979209 62165315 62188095 00701005228 REV. SHELL LINER 10D 28X52 61979218 00701005428 REV. SHELL LINER 10D 28X54 61787382 62077039 00701005628 REV. SHELL LINER 10D 28X56 61799041 61976886 62165323 62188094 00701005828 REV. SHELL LINER 10D 28X58 61886620 62103434 00701006028 REV. SHELL LINER 10D 28X60 61979220 61979221 62077046 00701006228 REV. SHELL LINER 10D 28X62 61986244 62101503 62192380 00701006628 REV. SHELL LINE 10D 28X66 61787381 61979212 62042739 62042740 00702004828 REV. SHELL LINER 20D 28X48 61987076 00702005028 REV. SHELL LINER 20D 28X50 61987075 00702005228 REV. SHELL LINER 20D 28X52 62102429 00702005428 REV. SHELL LINER 20D 28X54 62103435 00702005628 REV. SHELL LINER 20D 28X56 61964049 62029515 62077034 62102329 00702006028 REV. SHELL LINER 20D 28X60 61787385 61853155 00702006228 REV. SHELL LINER 20D 28X62 61915568 61979214 62102867 00702006628 REV. SHELL LINER 20D 28X66 61787383 61787384 62102865
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.