—#116723

Product

Stryker Orthopaedics Baseplate Impactor Extractor TRIATHLON Instruments. Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430 USA A subsidiary of Stryker Corporation. Made in USA. Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881 MEYZIEU Cedex France The Baseplate Impactor Extractor is intended to securely attach to the tibial baseplate or baseplate trial for impaction and extraction during surgery.

FDA product code: JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
Affected lot / code info: Catalog Number 6541-4-805. Lot Numbers: RD4V204; RD5V234; RD5V235; RD5V235A; RD5V235Y; RD5V236; RD5V236A; RD5V237; RD6A009; RD6A010; RD6A011; RD6A011P; RD6A012; RD6A051; RD6A052; RD6A053; RD6A053M; RD6A053T; RD6A061; RD6A061A; RD6A062; RD6A062N; RD6A063; RD6A063T; RD6A065; RD6A065D; RD6A065T; RD6A066; RD6A066A; RD6C103; RD6C103L; RD6C104; RD6C104Y; RD6C105; RD6C105M; RD6C105T; RD6C106; RD6C106A; RD6C108; RD6C109; RD6C109L; RD6C126; RD6H178; RD6H184; RD6H187; RD6L222; RD6L223; RD6L223A; RD6L224; RD6L224A; RD6L226; RD6L227; RD6L227A; RD6L227N; RD6M148; RD6M158; RD6M159; RD6M161; RD6M163; RD6M163A; RD6M163L; RD6M164; RD6M164A; RD6M165; RD6N046; RD6N046L; RD6N047; RD6N047N; RD6N048; RD6N052; RD6N052T; RD6N053; RD6N054; RD6N072; RD6N072H; RD6N073; RD6N074; RD6N074J; RD6N158; RD6N159; RD6N160; RD6S054; RD6S055; RD6S055A; RD6S056; RD6S081; RD6S082; RD6S082Y; RD6S083; RD6S083Y; RD6S084; RD6S084A; RD6S085; RD6S085Y; RD6S142; RD6S142Y; RD6S143; RD6S143A; RD6S144; RD6S144Y.

Why it was recalled

Stryker received reports from the field indicating that the handle detached from the cam of the Baseplate Impactor/Extractor Assembly.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Stryker sent Notification Letters/Product Accountablility Forms dated March 1, 2013 via FedEx to their Branches/Agencies on March 1, 2013.. Notification Letters/Product Recall Acknowledgement Forms dated March 4, 2013, were sent via FedEx to Hospital Risk Management on March 4, 2013. The Notification letters identified the product, the problem, and instructed customers on how to identify affected product; informs customers of the issues and potential hazards with the affected product and instructs them to contact their representative to arrange for return/replacement of any affected product. Customers are also asked to fax back the provided "Urgent Medical Device Removal Notification Acknowledgement Form" to Stryker within 5 days of receipt. Customers with questions were instructed to call 201-972-2100. For questions regarding this recall call 201-831-5523.

Recalling firm

Firm: Stryker Howmedica Osteonics Corp.
Address: 325 Corporate Drive, Mahwah, New Jersey 07430

Distribution

Distribution pattern: Worldwide Distribution - USA (nationwide) and internationally to Canada, Japan, Australia, China, New Zealand, France, Italy, Netherlands, Poland, Spain, Sweden, Switzerland and the United Kingdom.

Timeline

Recall initiated: 2013-02-23
Posted by FDA: 2013-04-05
Terminated: 2015-06-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #116723. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.