Z-0112-2017Class II

Sagittal Blade 18.0X0.97X90MM, Model Number: 6118-097-090

Name: Z-0112-2017 Sagittal Blade 18.0X0.97X90MM, Model Number: 6118-097-090
Creator: Stryker Instruments Div. of Stryker Corporation
Published: 2016-08-17
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2016-08-17 / Terminated / root cause: packaging

FDA source

Stryker Instruments Div. of Stryker Corporation began a recall of Sagittal Blade 18.0X0.97X90MM, Model Number: 6118-097-090 Product Usage: Heavy duty Sagittal Blades are used to cut bone and bone related tissue in a variety... on 2016-08-17. FDA classified it as Class II and gives the reason as "Stryker Instruments is voluntarily recalling the Sagittal Blade 18.0X.97X90MM due to the potential for a sterile barrier breach in the product's packaging". 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-0112-2017
Classification: Class II
Status: Terminated
Initiated: 2016-08-17
Posted: 2016-10-18
Terminated: 2017-03-29
Recalling firm: Stryker Corp.
Product: Sagittal Blade 18.0X0.97X90MM, Model Number: 6118-097-090 Product Usage: Heavy duty Sagittal Blades are used to cut bone and bone related tissue in a variety of orthopedic procedures. Typical procedures include, total-knee, uni-compartmental knee, hip, shoulder and ankle procedures. These blades can be used with the following handpieces; 4208-000-000 (SYSTEM 5 SAGITTAL SAW) 6208-000-000 (SYSTEM 6 SAG SAW) 6298-000-000 (ES6 SAGITTAL SAW) 7208-000-000 (SYSTEM 7 SAG SAW)
Product code: HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
Reason for recall: Stryker Instruments is voluntarily recalling the Sagittal Blade 18.0X.97X90MM due to the potential for a sterile barrier breach in the product's packaging.
Root cause tag: packaging
FDA root cause: Packaging
Action: Stryker Instruments is voluntarily recalling the Sagittal Blade 18.0X.97X90MM, product number 6118-097-090, lot number 16029017, due to a breach in the packaging causing a breach in sterility. There is a potential for a bone or soft tissue infection which may require medical or surgical intervention. Customer notices were issued via certified mail on 08/17/2016. Actions to be taken by the Customer/User: 1. Immediately review this Recall Notification. 2. Check all stock areas and/or operating room storage to determine how many Sagittal Blades from the affected lot (listed above) are at your facility. Quarantine and discontinue use of the recalled Sagittal Blades. 3. Complete the enclosed Business Reply Form (BRF) to confirm receipt of this notification and identify how many, if any, affected items are currently in your inventory. Please complete and return the BRF even if customers dont have any affected product on hand. Note: Customer signature on the BRF indicates that you received and understand this Notification and have followed the instructions in the Notification. 4. If customers have further distributed this product, please forward the recall letters and the attached BRF to all affected locations. Please indicate each location on the BRF. 5. Fax the completed BRF to Stryker Instruments Regulatory Department at 866-521-2762, or scan and email a copy to [email protected]. 6. If the BRF for customer facilities indicates that recalled product is currently on hand, a FedEx label will be emailed to you. This shipping label should be used to return recalled product. 7. Upon receipt of the recalled product, replacement product will be shipped to customer accounts. For questions regarding this recall, please contact Stryker Instruments: Kelly Jo Davis, 269-389-2921, [email protected]
Quantity in commerce: 225
Distribution: US Nationwide in the states of RI, WA, CA, CO, WI,FL, ID, ND, MD,TX Foreign: Australia, New Zealand, Netherlands, France, Italy
Product codes and lots: Sagittal Blade 18.0X0.97X90MM, Model Number: 6118-097-090, Lot # 16029017

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0112-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0112-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-17

Product code HWE

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)