FDA Device recall Z-1260-2014
Apollo" Knee System: PS TIB INS SZ0/16MM APOLL PS TIB INS SZ0/19MM APOLL PS TIB INS SZ0/22MM APOLL PS TIB INS SZ1/16MM APOLL PS TIB INS SZ2…
- FDA Device
- Class II
- terminated
- Published 2014-03-26
On 2014-03-26 the FDA classified a Class II recall of Apollo" Knee System: PS TIB INS SZ0/16MM APOLL PS TIB INS SZ0/19MM APOLL PS TIB INS SZ0/22MM APOLL PS TIB INS SZ1/16MM APOLL PS TIB INS SZ2… by Zimmer, citing A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was adva….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1260-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-02-25 |
| Published | 2014-03-26 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Zimmer |
| Distribution | US |
Product
Apollo" Knee System: PS TIB INS SZ0/16MM APOLL PS TIB INS SZ0/19MM APOLL PS TIB INS SZ0/22MM APOLL PS TIB INS SZ1/16MM APOLL PS TIB INS SZ2/16M APOLLO PS TIB INS SZ2/22MM APOLL PS TIB INS SZ3/16MM APOLL PS TIB INS SZ3/19MM APOLL PS TIB INS SZ4/9MM APOLLO PS TIB INS SZ4/11MM APOLL PS TIB INS SZ4/13MM APOLL PS TIB INS SZ4/16MM APOLL PS TIB INS SZ4/19MM APOLL PS TIB INS SZ4/22MM APOLL PS TIB INS SZ5/9MM APOLLO PS TIB INS SZ5/19MM APOLL
Reason
A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was advanced prematurely as a result of the machined component being stored in a transparent container exposed to artificial light for six years prior to inert packaging and sterilization of the device.
Identifiers
| code_info | Item Number Item Number 681600016 681600019 681600022 681601016 681602016 681602022 681603016 681603019 68160…Item Number Item Number 681600016 681600019 681600022 681601016 681602016 681602022 681603016 681603019 681604009 681604011 681604013 681604016 681604019 681604022 681605009 681605019 |
|---|
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-1260-2014%22
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