Z-1215-2019Class II

Performance Series Sagittal Blade, Catalog Number 6125-127-100

Name: Z-1215-2019 Performance Series Sagittal Blade, Catalog Number 6125-127-100
Creator: Stryker Instruments Div. of Stryker Corporation
Published: 2019-03-19
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2019-03-19 / Terminated / root cause: packaging

FDA source

Stryker Instruments Div. of Stryker Corporation began a recall of 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... on 2019-03-19. FDA classified it as Class II and gives the reason as "During manufacture, packaging materials for a small portion of the lot may not have been properly positioned, resulting in a potential breach in sterility". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1215-2019
Classification: Class II
Status: Terminated
Initiated: 2019-03-19
Posted: 2019-04-24
Terminated: 2020-06-26
Recalling firm: Stryker Corp.
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.
Product code: GFA Blade, Saw, General & Plastic Surgery, Surgical
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.
Root cause tag: packaging
FDA 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 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 [email protected].
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.
Product codes and lots: Serial/Lot Number 18247037

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1215-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1215-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-01	2019-04-24

Product code GFA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)