CLASS II Device recall · Reported 17 Apr 2013 · FDA Enforcement Report
Stryker Orthopaedics Baseplate Impactor Extractor Triathlon recalled
Stryker Howmedica Osteonics is recalling Stryker Orthopaedics Baseplate Impactor Extractor Triathlon Instruments, distributed nationwide in the US. The recall was initiated on 23 Feb 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1061-2013
- FDA event ID
- 64655
- Recalling firm
- Stryker Howmedica Osteonics, Mahwah, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Feb 2013
- FDA classified
- 5 Apr 2013
- Reported
- 17 Apr 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Hip & Knee Implants
Timeline
| 23 Feb 2013 | Recall initiated by company | |
| 5 Apr 2013 | Classified by FDA | +41 days |
| 17 Apr 2013 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Stryker received reports from the field indicating that the handle detached from the cam of the Baseplate Impactor/Extractor Assembly.
Product as listed by the FDA
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.
Where it was distributed
Worldwide Distribution - USA (nationwide) and internationally to Canada, Japan, Australia, China, New Zealand, France, Italy, Netherlands, Poland, Spain, Sweden, Switzerland and the United Kingdom.
Questions about this recall
Is Stryker Orthopaedics Baseplate Impactor Extractor Triathlon Instruments recalled?
Yes. Stryker Howmedica Osteonics recalled Stryker Orthopaedics Baseplate Impactor Extractor Triathlon Instruments on 23 Feb 2013. The recall is Class II and its status is Terminated. Recall number Z-1061-2013.
Why was it recalled?
Stryker received reports from the field indicating that the handle detached from the cam of the Baseplate Impactor/Extractor Assembly.
Which lots are affected?
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.
Where was it sold?
Worldwide Distribution - USA (nationwide) and internationally to Canada, Japan, Australia, China, New Zealand, France, Italy, Netherlands, Poland, Spain, Sweden, Switzerland and the United Kingdom.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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