Recall Z-0916-2007 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Exactech, Inc.
AcuMatch M-Series Straight Fluted Stem Segment and AcuMatch M-Series Curved Fluted Stem Segment. Catalog numbers 150-07-19 and 150-07-44.
| Date | Jun 9, 2007 (initiated Jul 21, 2006) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | The consignees were contacted by fax and email (dated July 21, 2006) to inform them of the recall requesting return of product |
| Quantity | 6 |
| Distribution | World wide-Domestically distributed to one account in Alabama and internationally to Columbia and Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K993736 | EXACTECH ACUMATCH INTEGRATED HIP SYSTEM M-SERIES FEMORAL STEM COMPONENT Exactech, Inc., Jan 20, 2000 |