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.
Recall
- Recall Number
- Z-0235-2016
- Event Number
- 72456
- Firm
- Stryker Sustainability Solutions
- FEI Number
- 3009350690
- Product Code
- GFA
- Status
- Terminated
- Root Cause
- Employee error
- Initiated
- October 14, 2015
- Terminated
- May 6, 2016
- Address
- 1810 W Drake Dr, Tempe, AZ, 85283-4327
Description
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.
It was reported that packaging was not properly sealed.
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 if any devices from the affected lots remain in inventory. The form needs to be completed even if no affected product is found. Return the completed and signed form to the local Stryker Sustainability Sales Representative or email to to [email protected] If the form indicates that affected devices remain in inventory, a prepaid shipping label will be issued for the return of the product. Customers will receive a credit for all affected devices returned. For further questions, please call (888) 888-3433.
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.
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