Stryker Howmedica Osteonics Corp. The Triathlon Posteriorly Stabilized Femoral Component. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
The Triathlon Posteriorly Stabilized Femoral Component.
Brand
Stryker Howmedica Osteonics Corp.
Lot Codes / Batch Numbers
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.
Products Sold
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.
Stryker Howmedica Osteonics Corp. is recalling The Triathlon Posteriorly Stabilized Femoral Component. due to The fatigue testing of the Triathlon PS Femoral Component does not consistently meet the requirements of the finite element analysis predicted load as. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Notification letters and Product Accountability Froms have been sent via Fedex on 10/27/2004 with return receipt.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026