Recall Z-0195-2012
Stryker Instruments Div. of Stryker Corporation · initiated October 18, 2011
Product
IBO Blade, Right, for use with Stryker TPS Reciprocating Saw, REF 5100-37-901, 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.
Codes / lots: 06213017, 08269017, 06230017, 08297027, 06247017, 08322017, 06257017, 08325017, 06279017, 09020017, 06306017, 09050017, 06355027, 09083017, 07025017, 09135017, 07043017, 09209017, 07067017, 09233017, 07080017, 09246017, 07114017, 09330017, 07157017, 10046017, 07172017, 10074017, 07183017, 10083017, 07197017, 10091017, 07211017, 10180017, 07220017, 10194017, 07246017, 10217017, 07282017, 10231017, 07323017, 10266017, 07356017, 10272017, 08003017, 10327027, 08017017, 10335017, 08049017, 11004017, 08064017, 11012017, 08078017, 11080017, 08141017, 11119017, 08206017, 11153017, 08248017, 11165017.
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
FDA-determined cause: Device Design
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.
Details
- Recall number
- Z-0195-2012
- Initiated
- October 18, 2011
- Posted by FDA
- November 16, 2011
- Terminated
- July 12, 2013
- Product code
- DZJ – Driver, Wire, And Bone Drill, Manual
- Quantity
- 5,691
- 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.
- Recalling firm
- Stryker Instruments Div. of Stryker Corporation, Portage, MI
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0196-2012 | IBO Blade, Left, for use with Stryker TPS Reciprocating Saw, REF 5100-37-902, Stryker…There is a potential for these blades to break where the blade is welded on to the arbor. This hazard can… | 10/18/2011Terminated |
| Z-0197-2012 | Right/Left IBO Blade Set, for use with Stryker TPS Reciprocating Saw, REF 5100-37-903…There is a potential for these blades to break where the blade is welded on to the arbor. This hazard can… | 10/18/2011Terminated |
| Z-0198-2012 | Right IBO Blade , for use with Stryker TPS Reciprocating Saw, REF 5100-37-901S2, Stryker…There is a potential for these blades to break where the blade is welded on to the arbor. This hazard can… | 10/18/2011Terminated |
| Z-0199-2012 | Left IBO Blade , for use with Stryker TPS or Core Reciprocating Saw, REF 5100-37-902S2…There is a potential for these blades to break where the blade is welded on to the arbor. This hazard can… | 10/18/2011Terminated |