| Class 2 Device Recall MIS (Minimally Invasive Surgery) Toolsteel Burs | |
Date Initiated by Firm | November 30, 2016 |
Date Posted | December 21, 2016 |
Recall Status1 |
Terminated 3 on June 01, 2017 |
Recall Number | Z-0873-2017 |
Recall Event ID |
75819 |
Product Classification |
Drills, burrs, trephines & accessories (simple, powered) - Product Code HBE
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Product | 8450-009-030 3.0MM Precision Round, 13CM, single use, Sterile
The Stryker MIS (Minimally Invasive Surgery) product offering, is used to remove osseous material during surgical cases.
Each cutting accessory consists of:
" A shank (B) with a notch (A), that fits in the attachment on one end and is connected to the head of the bur on the other end.
" A head (C) connected to the shank (B) and removes material using machined flutes. The head is machined directly on the shank/neck of the bur. |
Code Information |
Lot Number:16032017, Product Number: 8450-009-030 |
Recalling Firm/ Manufacturer |
Stryker Instruments Div. of Stryker Corporation 4100 E Milham Ave Portage MI 49002-9704
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For Additional Information Contact | Kelly Jo Davis 269-323-7700 |
Manufacturer Reason for Recall | Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because the burs may exhibit signs of corrosion. |
FDA Determined Cause 2 | Storage |
Action | The firm, Stryker Instruments, sent an "URGENT MEDICAL DEVICE RECALL NOTIFICATION" letter dated November 2016 to its Customers Overnight service, FedEx on November 30, 2016. The letter described the product, problems and actions to be taken. Stryker Sales Representatives and Stryker International will be notified via email. Customers are instructed to do the following:
1. Immediately review the Recall Notification.
2. Check all stock areas and/or operating room storage to determine how many affected Burs from the affected lots are at your facility. Quarantine and discontinue use of the recalled Burs.
3. Complete the enclosed Business Reply Form (BRF) to confirm receipt of the notification and identify how many, if any, affected items are currently in your inventory. Please complete and return the BRF even if you dont have any
affected product on hand. Fax the completed BRF to Stryker Instruments Regulatory Department at 866-521-2762, or scan and email a copy to StrykerInstrumentsRecalls@stryker.com.
Note: Your signature on the BRF indicates that you received and understand this Notification and have followed the instructions in the Notification.
4. If you have further distributed this product, please forward this letter and the attached BRF to all affected locations. Please indicate each location on the BRF.
5. Fax the completed BRF to Stryker Instruments Regulatory Department at 866-521-2762, or scan and email a copy to StrykerInstrumentsRecalls@stryker.com.
6. If the BRF for your facility indicates that recalled product is currently on hand, a FedEx label will be emailed to you. This shipping label should be used to return recalled product. Upon receipt of the recalled product, a credit will be
issued to your account.
Recalled products will be destroyed, packaging will be defaced, opened and discarded. Product will be discarded.
For questions regarding this recall, please contact Stryker Instruments: StrykerInstrumentsRecalls@stryker.com, or
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Quantity in Commerce | 1,257 in total |
Distribution | Worldwide Distribution - US (nationwide) including states of: AK, AL, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NM, NY, OH, OK, PA, SC, TN, TX, VA, WA, WI and countries of: Canada, Japan, Venlo (Netherlands), France, and UK (United Kingdom). |
Total Product Life Cycle | TPLC Device Report |
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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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