Z-0197-2012

Right/Left IBO Blade Set, for use with Stryker TPS Reciprocating Saw, REF 5100-37-903, Stryker Instruments...

Name: Z-0197-2012 Right/Left IBO Blade Set, for use with Stryker TPS Reciprocating Saw, REF 5100-37-903, Stryker Instruments...
Creator: Stryker Instruments Div. of Stryker Corporation
Published: 2011-10-18
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2011-10-18 / Terminated / root cause: design

FDA source

Stryker Instruments Div. of Stryker Corporation began a recall of Right/Left IBO Blade Set, for use with Stryker TPS Reciprocating Saw, REF 5100-37-903, Stryker Instruments, Kalamazoo, MI. Product Usage: The intended use of... on 2011-10-18. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0197-2012
Status: Terminated
Initiated: 2011-10-18
Posted: 2011-11-16
Terminated: 2013-07-12
Recalling firm: Stryker Corp.
Product: Right/Left IBO Blade Set, for use with Stryker TPS Reciprocating Saw, REF 5100-37-903, 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.
Product code: DZJ Driver, Wire, And Bone Drill, Manual
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
Root cause tag: design
FDA root cause: Device Design
Action: 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.
Quantity in commerce: 1,086 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.
Product codes and lots: 06216017, 06230017, 06247017, 06313017, 06354017, 07067017, 07110017, 07183017, 07190017, 07225017, 07246017, 07323017, 08141017, 08269017, 08336017, 09021017, 09050017, 09083017, 09135017, 09317017, 10085017, 10091017, 10117017, 10148017, 10194017, 10217017, 10327017, 11010017, 11100017, 11119017, 11159017, 11167017,

Product code DZJ

K040369Class IIStryker Consolidated Operating Room Equipment (Core) SystemStryker Instruments / cleared 2004-04-01

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)