Citation TMZF HA 132 degrees Neck Angle, V40 Hip Stem - Right Size #3: catalog # 6265-5113 , Left Size #4: catalog #6265
FDA device recall Z-1317-2014 · posted 2014-04-02 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- Stryker received a report from the field indicating that a citation TMZF HA 132 degrees neck angle V40 Hip Stem - Left Size # 4 was identified in a packaging associated with a citation TMZF HA 132 degrees Neck Angle V40 Hip Stem - Right Size #3.
- Action taken
- Stryker sent an Urgent Medical Device Recall Notification letters and Product Accountability Forms to Hospital Risk Management, Chief of Orthopaedics, and Surgeons via Fed Ex with return receipt on February 26, 2014. The letter identified the affected product, problem and actions to be taken. Customer were instructed to return the affected product to the attention of Regulatory Compliance. Please attach the fluorescent orange PRODUCT REMEDIATION sticker to your return. For questions call 201-972-2100.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- MEH
- Quantity affected
- 48 units
- Distribution
- USA Nationwide Distribution
- Date initiated
- 2014-02-03
- Date posted
- 2014-04-02
- Date terminated
- 2014-12-02
- Location
- Mahwah, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CITATION TMZF HA STEM (K993768) | Howmedica Osteonics Corp. | 2000-01-21 |