Recall Z-0467-2014— Stryker Howmedica Osteonics Corp.
Class II · Terminated
Class II FDA medical device recall by Stryker Howmedica Osteonics Corp., initiated 2013-10-25, terminated 2015-03-31. It names one FDA 510(k) clearance: K120578. 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..
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-10-25
- Terminated
- 2015-03-31
- Firm location
- Mahwah, NJ, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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 for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.