Sagittal Blade 18.0X0.97X90MM, Model Number: 6118-097-090 Product Usage: Heavy duty Sagittal Blades are used to cut bone

FDA device recall Z-0112-2017 · posted 2016-10-18 · Terminated

Recall details

Recalling firm

Stryker Instruments Div. of Stryker Corporation

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.

Action taken

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 kellyjo.davis@stryker.com. 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, kellyjo.davis@stryker.com

Root cause

Packaging

Status

Terminated

Product code

HWE

Quantity affected

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

Date initiated

2016-08-17

Date posted

2016-10-18

Date terminated

2017-03-29

Location

Portage, MI