Stryker Instruments Div. of Stryker Corporation: 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.

Recall number

Z-0197-2012

Recalling firm

Stryker Instruments Div. of Stryker Corporation

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.

Status

Terminated

Initiated

2011-10-18

Posted

2011-11-16

Terminated

2013-07-12

Reason

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

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

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.

Lot, serial or model codes

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,

510(k) numbers

["K040369"]

PMA numbers

not on file

Product code

DZJ

Firm FEI

1811755

Firm city

Portage

Firm state

MI

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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