Recall Z-2360-2010 ยท BXN Stimulator, Nerve, Battery-Powered
Stryker Instruments Div. of Stryker Corporation
Poly Stim II Nerve Stimulator 8 inch for use with Stryker Pain Pump, REF 550-100, Rx, Sterile, Distributed by: Stryker Instruments, Kalamazoo, MI.
| Date | Sep 3, 2010 (initiated Feb 1, 2010) |
| Status | Terminated |
| Reason | Device may malfunction and lead to ineffective stimulation, which could delay finding the nerve and the effects of the nerve block. |
| Root cause | Process control |
| Action | Stryker Instruments issued an "Urgent Medical Device Recall Notification" letter to consignee risk managers, directors and material managers on February 2, 2010, identifying the affected devices and product issues. The consignees were instructed to: 1) Forward the recall notice and reply form to all affected locations. 2) Review all inventory and quarantine affected product. 3) Destroy all affected product using attached instructions. 4) Complete and return the Business Reply Form to the firm by fax. Stryker Instruments can be contacted at 1-9800-800-4236 ext 4354 |
| Quantity | 18,826 all products |
| Distribution | Nationwide Distribution: United States, including the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, and UT. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K990323 | TE ME NA POLYSTIM NERVE STIMILATOR Te ME NA S.A.R.L., Sep 28, 2001 |