Recall Z-0529-2010 ยท HTS Knife, Orthopedic
Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics Sterile Knee Instrument, Patella Cutter; Stainless Steel, Disposable; Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430 33 mm size, One single unit to a package. Note: The 30 mm instruments were not distributed. The patella cutters are components of the Xcelerate Instruments and are used with additional devices to remove bone from the patella in preparation fo
| Date | Dec 15, 2009 (initiated Nov 11, 2009) |
| Status | Terminated |
| Reason | Disposable Patella Cutters - 30 mm (catalog number 8000-0030, lot V31257001) were packaged and labeled as 33 mm Disposable Patella Cutters (catalog number 8000-0033, lot V31257001 and vice versa. |
| Root cause | Labeling mix-ups |
| Action | An "Urgent Product Recall" letter dated November 11, 2009 was sent to all affected Stryker branches, hospital risk management, hospital Chief or Orthopaedics and surgeons by Federal Express. The letter described the issue, potential hazards and risk mitigation factors and requested that the Recall Acknowledgement form be completed and returned. The Recall Acknowledgement form has information regarding the return of affected product to the firm. Direct questions to Stryker Orthopaedics by calling 1-201-831-5832. |
| Quantity | 12 |
| Distribution | Nationwide Distribution (MA, NJ, FL, TN, OR and NY). |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.