Recall Z-0922-2011 ยท GCJ Laparoscope, General & Plastic Surgery
Stryker Endoscopy
Stryker brand Cart with Isolation Transformer, Model Numbers: 240-099-001, 240-099-001K, 240-099-011, 240-099-011K, 240-099-020, 240-099-020K, 240-099-050, 240-099-072. 240-099-001, 240-099-001K, 240-099-011, 240-099-011K, 240-099-020, 240-099-020K, 240-099-050, 240-099-072, Product is manufactured and distributed by Stryker Endoscopy San Jose, CA The product is indicated for use in the carts i
| Date | Jan 19, 2011 (initiated Apr 16, 2010) |
| Status | Terminated |
| Reason | The electrical cord power plug design may allow the prongs to develop a fracture inside or outside the plug, if the plug is misused. |
| Root cause | Device Design |
| Action | Stryker Endoscopy sent an URGENT: Device Recall letter dated April 16, 2010, to Stryker Sales reps and all customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to: Locate the affected units. Visually inspect each cord for damage. If the cord has bent or cracked prongs the unit should be taken out of service immediately. The customer was instructed to call a Regulatory Affairs Recall Representative at (408) 754-2738 for further instruction. If the cord did not show signs of damage, it could remain in service. An a |
| Quantity | 7371 |
| Distribution | Worldwide Distribution - USA including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, ID, IL, IN, IA, KS, KY, LA, MA, ME, MI, MN, MS, MO, MT, NE, NH, NJ, NM, NV, MY, NC, ND, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY and the countries of Canada, Chile, China, India, Korea, Mexico, Singapore |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K935234 | STRYKER ENDOSCOPIC VIDEO ACCESSORIES Stryker Endoscopy, Mar 18, 1994 |