IBO Blade, Left, for use with Stryker TPS Reciprocating Saw, REF 5100-37-902, Stryker Instruments, Kalamazoo, MI. Produc

FDA device recall Z-0196-2012 · posted 2011-11-16 · Terminated

Recall details

Recalling firm

Stryker Instruments Div. of Stryker Corporation

Reason for recall

There is a potential for these blades to break where the blade is welded on to the arbor. This hazard can result in the following harms: tissue damage due to the broken blade being aspirated or swallowed, additional surgery to remove a broken blade, infection due to an unretrieved device component, complications associated with increased time under anesthesia to retrieve a broken blade, osteomyeli

Action taken

The firm, Stryker, sent an "URGENT MEDICAL DEVICE RECALL NOTIFICATION" letter dated October 18, 2011 to Risk Managers, Office Managers, and Oral Surgeons. The letter described the products under recall, the problem and a series of actions to be taken. Customers were asked to immediately locate recalled products and quarantine. Products were to be shipped back to Stryker. The letter included a Business Reply Form to be faxed back to Stryker Instruments Regulatory Department, 866-521-2762. The letter instructs to forward this notification to all affected locations if the recalled products were further distributed. Customers with questions can call Stryker at 1-800-253-3210.

Root cause

Device Design

Status

Terminated

Product code

DZJ

Quantity affected

5,634 units

Distribution

Worldwide Distribution - USA (nationwide) and the countries of Brazil, Canada, China, Germany, Greece, Hong Kong, India, Jordan, Miramar, Saudi Arabia, Singapore, Spain, Switzerland, United Kingdom.

Date initiated

2011-10-18

Date posted

2011-11-16

Date terminated

2013-07-12

Location

Portage, MI

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