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U.S. Department of Health and Human Services

Class 2 Device Recall Performance Series Sagittal Blade

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  Class 2 Device Recall Performance Series Sagittal Blade see related information
Date Initiated by Firm March 19, 2019
Create Date April 24, 2019
Recall Status1 Terminated 3 on June 26, 2020
Recall Number Z-1215-2019
Recall Event ID 82562
Product Classification Blade, saw, general & plastic surgery, surgical - Product Code GFA
Product Performance Series Sagittal Blade, Catalog Number 6125-127-100

Product Usage:
The Stryker Heavy Duty Sagittal Blades are used in the cutting and shaping of bone and other bone related tissue in various orthopedic procedures. Typical procedures include, total-knee, uni-compartmental knee, hip, shoulder, ankle and orthopedic trauma procedures. The intended part of the body will be the areas associated with the above procedures. These products will be used in a fully equipped OR suite by surgeons.
Code Information Serial/Lot Number 18247037
Recalling Firm/
Manufacturer		 Stryker Instruments Div. of Stryker Corporation
4100 E Milham Ave
Portage MI 49002-9704
For Additional Information Contact Kara Spath
269-389-4518
Manufacturer Reason
for Recall		 During manufacture, packaging materials for a small portion of the lot may not have been properly positioned, resulting in a potential breach in sterility.
FDA Determined
Cause 2		 Under Investigation by firm
Action Urgent Medical Device Recall Notification letters dated 3/19/19 were sent to customers. The letter identified the affected product, problem and actions to be taken. Immediately review the Recall Notification and this Business Reply Form. 2. Immediately check all stock areas and/or operating room storage for affected products. Quarantine and discontinue use of any Performance Series Sagittal Blades from lot 18247037. 3. Complete this Business Reply Form (BRF) to confirm receipt of this Notification and identify how many 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 at 8665212762, or email to kara.spath@stryker.com.
Quantity in Commerce 355
Distribution US Nationwide in the states of: FL, GA, ID, KY, MA, MD, MN, NC, PA, UT, WA, and WI. The products were distributed to the following foreign countries: Canada, France, Italy, Netherlands.
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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