Poly Stim II Nerve Stimulator 8 inch for use with Stryker Pain Pump, REF 550-100, Rx, Sterile, Distributed by: Stryker Instruments, Kalamazoo, MI.
This recall has been terminated (originally issued September 3, 2010).
- Recall Initiated
- February 1, 2010
- Posted
- September 3, 2010
- Terminated
- March 28, 2011
- Recall Number
- Z-2360-2010
- Quantity
- 18,826 all products
- Firm Location
- Kalamazoo, MI
- Official Source
- View on FDA website ↗
Reason for Recall
Device may malfunction and lead to ineffective stimulation, which could delay finding the nerve and the effects of the nerve block.
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.
Lot / Code Info
0507702223, 0524301373 and 0603705603.
Root Cause
Process control
Action Taken
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