—#171839

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.

FDA product code: GFA — Blade, Saw, General & Plastic Surgery, Surgical
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: Serial/Lot Number 18247037

Why it was recalled

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 (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Stryker Instruments Div. of Stryker Corporation
Address: 4100 E Milham Ave, Portage, Michigan 49002-9704

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2019-03-19
Terminated: 2020-06-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #171839. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.