1) Accolade II 127 Neck Angle Hip Stem, Size # 3 2) Accolade II 127 Neck Angle Hip Stem, Size #5 Howmedica Osteonics Cor
FDA device recall Z-0467-2014 · posted 2013-12-07 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- 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.
- Action taken
- Stryker sent an e-mail to their domestic locations on 10/11/2013. Notification letters and product accountability forms were sent via Fed Ex on 10/25/2013 with return receipt to branches/agencies and hospital risk management, chief of orthopaedics and surgeons.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- JDI
- Quantity affected
- 20 units
- Distribution
- Nationwide Distribution including states: AL, GA, IL, and WA.
- Date initiated
- 2013-10-25
- Date posted
- 2013-12-07
- Date terminated
- 2015-03-31
- Location
- Mahwah, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACCOLADE II HIP STEM (K120578) | Howmedica Osteonics | 2012-03-29 |