Reported Aug 17, 2016 · Terminated
Stryker Orthopaedics Modular Handle Triathlon Instruments, Non-Sterile, REF 6541-4-808, Lot 123, NDC M546654148080S…
Stryker Howmedica Osteonics Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Stryker Howmedica Osteonics Corp. · 325 Corporate Dr · Mahwah, NJ · 07430-2006
Is this the product you have?
- Stryker Orthopaedics Modular Handle Triathlon Instruments, Non-Sterile, REF 6541-4-808, Lot 123
- NDC M546654148080S Product UsageIs a reusable instrument that is part of the Triathlon Primary total knee arthroplasty (TKA) system as well as the Triathlon Partial Knee Replacement (PKR) system. The use of the handles in Primary
- TKA is optional and may be used to(1) Assist in stabilizing the Triathlon Femoral Sizer, (2) Aid in stabilization during
- use and removal of the Triathlon 41 Cutting Block and (3) Aid in assembly of the Anterior MIS Distal Resection Guide to the Anterior Skim Cut Guide. Per the Triathlon PKR surgical protocol, the handle is required
- for a PKR surgery and is used to(1) Assemble and disassemble the Femoral Trial Drill Guide into the Femoral Trial and (2) Remove the Peg Trial from the Femoral Trial
- Lot codes and dates
159 of 159 codes
Catalog No. 6541-4-808 Lot Nos.: SB1K14SB1K14ASB1K14A1SB1K14PSB1K15SB1K15ASB1K15A1SB1K15A2SB1M25SB1M25ASB1M25A1SB1M25A2SB1M25A2X1SB1N02SB1N02ASB1N02A1SB1N02A2SB1N02A3SB1N02X1SB1T05SB1T05ASB1T05A1SB1T05AX1SB1T05AX2SB1T05KSB1V01SB1V01KSB1V01LSB1V01X1SB1V01X2SB1V01X3SB1W14SB1W14KSB1W14X1SB2T19SB2T19ASB2T19DSB2T19DX1SB2T19DX2SB2T19JSB2T19KSB2T19KX1SB2T19KX2SBT19X3SB2V87SB2V87ASB2V87JSB2V87JX1SB2V87KSB2V87XSB2V87X1SB2W23SB2W23GSB2W23XSB2W23X1SB3A20SB3A20ASB3A21SB3A21DSB3A21MSB3A21X
- Amount recalled
- 12,469 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
Stryker Orthopaedic is voluntarily recalling the Triathlon Modular Handle because analysis revealed that the press fit specifications between the dowel pin and the mating hole in the shaft were not being achieved potentially resulting in disassociation from the instrument.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Stryker Howmedica Osteonics Corp. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.