FDA Device recall Z-2055-2013
00 4309-049-00 Trabecular Metal Reverse Shoulder Glenosphere Distractor Rx, Non sterile (sterilize before use) The Glenosphere Distractor m…
- FDA Device
- Class II
- terminated
- Published 2013-09-04
On 2013-09-04 the FDA classified a Class II recall of 00 4309-049-00 Trabecular Metal Reverse Shoulder Glenosphere Distractor Rx, Non sterile (sterilize before use) The Glenosphere Distractor m… by Zimmer, citing zimmer is initiating a lot specific recall of the Trabecular Metal" Reverse Glenosphere Distractor due to the potential of the device not functioning properly should it be utilize….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2055-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-08-01 |
| Published | 2013-09-04 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Zimmer |
| Distribution | US |
Product
00 4309-049-00 Trabecular Metal Reverse Shoulder Glenosphere Distractor Rx, Non sterile (sterilize before use) The Glenosphere Distractor must be able to attach, connect, or mate with the Glenosphere and remove it without dislodging or loosening the base plate from the glenoid, or damaging the glenoid. Pulling the trigger releases a weight inside the Distractor. This force is transmitted to the bottom of the glenosphere dislodging it from the base plate.
Reason
Zimmer is initiating a lot specific recall of the Trabecular Metal" Reverse Glenosphere Distractor due to the potential of the device not functioning properly should it be utilized without proper lubrication. As a result, there is a potential for the device to fail to provide impact to the Glenosphere when the trigger is pulled. In addition, there is a potential for the foot of the device to fract
Identifiers
| code_info | Item # 00-4309-049-00 and Lot Numbers: 60452884, 60461858, 60531990, 60549559, 60605842, 60612781, 60684768, 60754281,…Item # 00-4309-049-00 and Lot Numbers: 60452884, 60461858, 60531990, 60549559, 60605842, 60612781, 60684768, 60754281, 60815778, 60909547, 60959086, 60978338, 61029048, 61135953, 61213252, 61274877, 61334929, 61431672, 61566464, 61594740, 61690097, 61756058, 61857748, 61858851, 61889174, 61906350, 61910781, 61918666 62039450, 62096379, 62101249, 62141887, 62160965, 62215378, 62254111, 62269856, 62304206, and 62311096. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2055-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.