Stryker Howmedica Osteonics Corp.: 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.

Recall number

Z-1061-2013

Recalling firm

Stryker Howmedica Osteonics Corp.

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.

Status

Terminated

Initiated

2013-02-23

Posted

2013-04-05

Terminated

2015-06-15

Reason

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

Root cause

Nonconforming Material/Component

Action

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.

Quantity

871 units

Distribution

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

Lot, serial or model codes

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.

510(k) numbers

not on file

PMA numbers

not on file

Product code

JWH

Firm FEI

3003070421

Firm city

Mahwah

Firm state

NJ

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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