FDA Device recall Z-0467-2014
1) Accolade II 127 Neck Angle Hip Stem, Size # 3 2) Accolade II 127 Neck Angle Hip Stem, Size #5 Howmedica Osteonics Corp. 325 Corporate Dr…
- FDA Device
- Class II
- terminated
- Published 2013-12-18
On 2013-12-18 the FDA classified a Class II recall of 1) Accolade II 127 Neck Angle Hip Stem, Size # 3 2) Accolade II 127 Neck Angle Hip Stem, Size #5 Howmedica Osteonics Corp. 325 Corporate Dr… by Stryker Howmedica Osteonics, citing stryker received a report from the field indicating that an Accolade II Hip Stem Size #3 was identified in packaging with an Accolade II Hip Stem Size #5.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0467-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-10-25 |
| Published | 2013-12-18 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Stryker Howmedica Osteonics |
| Distribution | US |
Product
1) Accolade II 127 Neck Angle Hip Stem, Size # 3 2) Accolade II 127 Neck Angle Hip Stem, Size #5 Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 USA Telephone # +1 201-831-5000 Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881 MEYZIEU Cedex France Intended for cementless application in total or hemiarthroplasty procedures.
Reason
Stryker received a report from the field indicating that an Accolade II Hip Stem Size #3 was identified in packaging with an Accolade II Hip Stem Size #5.
Identifiers
| code_info | 510K K120578 Accolade II I27 Neck Angle Hip Stem, Size # 3 Catalog No.# 6721-0330 Lot Code #44416307 Accolade II…510K K120578 Accolade II I27 Neck Angle Hip Stem, Size # 3 Catalog No.# 6721-0330 Lot Code #44416307 Accolade II 127 Neck Angle Hip Stem, Size #5 Catalog No. # 6721-0535 Lot Code 44564405 |
|---|
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-0467-2014%22
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