—#35769

Product

The Triathlon Posteriorly Stabilized Femoral Component.

FDA product code: NPJ — Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
Affected lot / code info: Catalog Number--Lot Code: 5511-F-301--ER0215; 5511-F-301--PR04139; 5511-F-301--PR04664; 5511-F-301--PR04862; 5511-F-301--PR04891; 5511-F-301--PR04955; 5511-F-301--PR41122; 5511-F-301--PR4352; 5511-F-301--PR4424; 5511-F-301--PR4425; 5511-F-301--PR4427; 5511-F-301--PR4519; 5511-F-301--PR4734; 5511-F-301--PR4736; 5511-F-302--ER0184; 5511-F-302--PR04795; 5511-F-302--PR04808; 5511-F-302--PR04809; 5511-F-302--PR04810; 5511-F-302--PR04840; 5511-F-302--PR04887; 5511-F-302--PR04902; 5511-F-302--PR4113; 5511-F-302--PR41142; 5511-F-302--PR41143; 5511-F-302--PR4256; 5511-F-302--PR42561; 5511-F-302--PR4429; 5511-F-302--PR4430; 5511-F-302--PR4432; 5511-F-302--PR4520; 5511-F-302--PR4727; 5511-F-302--PR4738; 5511-F-302--PR4739; 5511-F-302--PR4774; 5511-F-302--PRO4626; 5511-F-302--PRO4627; 5511-F-302--PRO4629; 5511-F-401--PR04811; 5511-F-401--PR04848; 5511-F-401--PR04849; 5511-F-401--PR04865; 5511-F-401--PR04866; 5511-F-401--PR04867; 5511-F-401--PR04881; 5511-F-401--PR04882; 5511-F-401--PR4107; 5511-F-401--PR41073; 5511-F-401--PR4115; 5511-F-401--PR4435; 5511-F-401--PR4437; 5511-F-401--PR4718; 5511-F-401--PR4740; 5511-F-401--PR4775; 5511-F-401--PR4779; 5511-F-402--ER0219; 5511-F-402--PR04805; 5511-F-402--PR04805; 5511-F-402--PR04806; 5511-F-402--PR04850; 5511-F-402--PR04851; 5511-F-402--PR04880; 5511-F-402--PR04905; 5511-F-402--PR04906; 5511-F-402--PR4116; 5511-F-402--PR4258; 5511-F-402--PR4440; 5511-F-402--PR4442; 5511-F-402--PR4443; 5511-F-402--PR4716; 5511-F-402--PR4728; 5511-F-402--PR4777; 5511-F-501--ER0217; 5511-F-501--ER0250; 5511-F-501--PR4117; 5511-F-501--PR4118; 5511-F-501--PR4254; 5511-F-501--PR42541; 5511-F-501--PR42593; 5511-F-501--PR4418; 5511-F-501--PR4444; 5511-F-501--PR4445; 5511-F-501--PR4446; 5511-F-501--PR4448; 5511-F-501--PR4449; 5511-F-501--PR4450; 5511-F-501--PR4452; 5511-F-501--PR4524; 5511-F-501--PR4767; 5511-F-502--ER0218; 5511-F-502--PR04884; 5511-F-502--PR04885; 5511-F-502--PR05008; 5511-F-502--PR41191; 5511-F-502--PR41194; 5511-F-502--PR4379; 5511-F-502--PR4456; 5511-F-502--PR4457; 5511-F-502--PR4458; 5511-F-502--PR4459; 5511-F-502--PR4460; 5511-F-502--PR4461; 5511-F-502--PR4525; 5511-F-502--PR4526; 5511-F-502--PR4527; 5511-F-502--PR4768; 5511-F-502--PR4778; 5511-F-601--ER0185; 5511-F-601--ER0280; 5511-F-601--PR04886; 5511-F-601--PR04904; 5511-F-601--PR05021; 5511-F-601--PR05052; 5511-F-601--PR05229; 5511-F-601--PR41421; 5511-F-601--PR41422; 5511-F-601--PR41423; 5511-F-601--PR4464; 5511-F-601--PR4528; 5511-F-601--PR4529; 5511-F-601--PR4752; 5511-F-601--PR4753; 5511-F-601--PR4798; 5511-F-601--PR5026; 5511-F-601--PR5032; 5511-F-601--PR5037; 5511-F-601--PR5046; 5511-F-601--PR5108; 5511-F-601--PR5110; 5511-F-602--ER0186; 5511-F-602--ER0253; 5511-F-602--ER0254; 5511-F-602--ER0265; 5511-F-602--J66915; 5511-F-602--PR04662; 5511-F-602--PR04828; 5511-F-602--PR04863; 5511-F-602--PRO4864; 5511-F-602--PR4099; 5511-F-602--PR42731; 5511-F-602--PR4470; 5511-F-602--PR4471; 5511-F-602--PR4472; 5511-F-602--PR4754; 5511-F-602--PR4757; 5511-F-602--PR4772; 5511-F-602--PR4776; 5511-F-602--PR4781; 5511-F-602--PR4901; 5511-F-602--PR5111; 5511-F-602--PR5112. Several units of the same lot number are reported in the quantity distributed.

Why it was recalled

The fatigue testing of the Triathlon PS Femoral Component does not consistently meet the requirements of the finite element analysis predicted load as delineated in the 510(k) submittal.

Root cause (FDA determination)

Other

Action the firm took

Notification letters and Product Accountability Froms have been sent via Fedex on 10/27/2004 with return receipt.

Recalling firm

Firm: Stryker Howmedica Osteonics Corp.
Address: 325 Corporate Dr, Mahwah, New Jersey 07430-2002

Distribution

Distribution pattern: The product is distributed to its branches/agencies and to hospitals nationwide.

Timeline

Recall initiated: 2004-10-27
Posted by FDA: 2005-02-24
Terminated: 2005-05-31
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #35769. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.