—#104842

Product

IBO Blade, Left, for use with Stryker TPS Reciprocating Saw, REF 5100-37-902, Stryker Instruments, Kalamazoo, MI. Product Usage: The intended use of these devices is to cut bone and hard tissue in maxillofacial procedures and have been specifically designed for osteotomies of the mandibular ramus.

FDA product code: DZJ — Driver, Wire, And Bone Drill, Manual
Device class: Class 2
Medical specialty: Dental
510(k) numbers: K040369
Affected lot / code info: 06216017, 08336017, 06237017, 09021017, 06247017, 09050017, 06257017, 09083017, 06327017, 09135017, 06355017, 09197017, 07015017, 09209017, 07043017, 09231017, 07115017, 09233017, 07141017, 09246017, 07172017, 10027017, 07185017, 10046017, 07208017, 10091017, 07220017, 10148017, 07236017, 10188017, 07282017, 10217017, 07323017, 10228017, 08003017, 10251017, 08052017, 10267017, 08067017, 10327017, 08078017, 10335017, 08141017, 11004017, 08206017, 11012017, 08213017, 11098017, 08268017, 11118017, 08301017, 11159017, 08322017, 11165017.

Why it was recalled

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

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

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

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2011-10-18
Posted by FDA: 2011-11-16
Terminated: 2013-07-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #104842. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.