Recall Z-0235-2016 ยท GFA Blade, Saw, General & Plastic Surgery, Surgical
Stryker Sustainability Solutions
SSS Reprocessed Zimmer, Synthes, Stryker and Linvatec Drill Bits and Blades Surgical drill bits, blades, burs, chisels, rasps, taps and reamers are specially designed surgical accessories to help the surgeon cut and drill bone and bony structures. Reprocessed surgical accessories are indicated for use in patients requiring surgery involving bone and bony structures.
| Date | Oct 14, 2015 |
| Status | Terminated |
| Reason | It was reported that packaging was not properly sealed. |
| Root cause | Employee error |
| Action | Stryker sent an Urgent Medical Device Recall letter dated October 14, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The firm's letter states that the use of the affected lots of the recalled product should be discontinued. Other bit and/or blade lots reprocessed by Stryker Sustainability Solutions should be considered as alternatives. A Recall Effectiveness Check Form including the quantity of affected devices shipped is enclosed. The letter states to complete the Recall Effectiveness Check Form and indicate |
| Quantity | 1202 |
| Distribution | US ( nationwide) Distribution to the states of : MN, OH, CA, IN, WI, FL, GA, MO, IA, MT, LA, KS, TX, TN, WY, MD, NJ, WA, PA, SC, NY, MI, AT, HI, MN, AR, AZ, IL, IA, KY, MS, UT, NC, VA, CO, ME and ID., Internationally to Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.