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U.S. Department of Health and Human Services

Class 2 Device Recall SSS Reprocessed Zimmer, Synthes, Stryker and Linvatec Drill Bits and Blades

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  Class 2 Device Recall SSS Reprocessed Zimmer, Synthes, Stryker and Linvatec Drill Bits and Blades see related information
Date Initiated by Firm October 14, 2015
Create Date November 06, 2015
Recall Status1 Terminated 3 on May 06, 2016
Recall Number Z-0235-2016
Recall Event ID 72456
Product Classification Blade, saw, general & plastic surgery, surgical - Product Code GFA
Product 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.
Code Information Item No/Model No: 2108-109, 4125-127-090, 2108-110, 2108-115, 2108-120, 2108-151-001, 2108-152, 2108-158, 2108-182, 2108-218, 310.25, 4118-127-090, 4125-147-090, 4806-110-25, 5071-553, 6118-127-90, 6125-127-090  Lot Code: 3743743, 3750611, 3750630, 3753894, 3761982, 3775827, 3779058, 3779129, 3782549, 3782554, 3782565, 3785624, 3785630, 3785676, 3789092, 3789102, 3794000, 3794085, 3796706, 3796799, 3799827, 3802103
Recalling Firm/
Manufacturer		 Stryker Sustainability Solutions
1810 W Drake Dr
Tempe AZ 85283-4327
For Additional Information Contact Chelsea Cullen
888-888-3433
Manufacturer Reason
for Recall		 It was reported that packaging was not properly sealed.
FDA Determined
Cause 2		 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 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 SSSPFA@stryker.com 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.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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