AcuMatch M-Series Straight Fluted Stem Segment and AcuMatch M-Series Curved Fluted Stem Segment. Catalog numbers 150-07-
FDA device recall Z-0916-2007 · posted 2007-06-09 · Terminated
Recall details
- Recalling firm
- Exactech, Inc.
- Reason for recall
- The packaging was mislabeled: Exterior and interior packaging on the device was labeled with catalog number 150-07-19 15mm x 200mm, however, the actual part inside the packaging was a 21mm x 200mm (catalog number 150-07-44) device.
- Action taken
- The consignees were contacted by fax and email (dated July 21, 2006) to inform them of the recall requesting return of product
- Root cause
- Other
- Status
- Terminated
- Product code
- LPH
- Quantity affected
- 6
- Distribution
- World wide-Domestically distributed to one account in Alabama and internationally to Columbia and Australia.
- Date initiated
- 2006-07-21
- Date posted
- 2007-06-09
- Date terminated
- 2012-05-06
- Location
- Gainesville, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EXACTECH ACUMATCH INTEGRATED HIP SYSTEM M-SERIES FEMORAL STEM COMPONENT (K993736) | Exactech, Inc. | 2000-01-20 |