Recall Z-1215-2019 ยท GFA Blade, Saw, General & Plastic Surgery, Surgical
Stryker Instruments Div. of Stryker Corporation
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 associa
| Date | Mar 19, 2019 |
| Status | Terminated |
| Reason | During manufacture, packaging materials for a small portion of the lot may not have been properly positioned, resulting in a potential breach in sterility. |
| Root cause | 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 retu |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.