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.
This recall has been terminated (originally issued March 19, 2019).
- Recall Initiated
- March 19, 2019
- Terminated
- June 26, 2020
- Recall Number
- Z-1215-2019
- Quantity
- 355
- Firm Location
- Portage, MI
- Official Source
- View on FDA website ↗
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.
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.
Lot / Code Info
Serial/Lot Number 18247037
Root Cause
Under Investigation by firm
Action Taken
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.