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Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp. Recalls

All product recalls associated with Stryker Howmedica Osteonics Corp..

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Recall Summary

Total Recalls

180

Past Year

Class I (Serious)

Most Recent

Dec 2014

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 101–120 of 180 recalls

Stryker Howmedica Osteonics Corp.: Stryker GMRS Proximal Femoral Surgical Protocol; Global M...

The GMRS Proximal Femoral Surgical Protocol states " The GMRS Proximal Femoral components are fully compatabile with all Stryker V40 femoral heads." This statement is incorrect and conflicts with the Alumina Head label and packaging insert.

FDADec 18, 2007Nationwide• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: Solar HA Humeral Stem with Plasma Coating 7mm to 17 mm ...

Delamination: Loosening of the titanium plasma coating on the product was observed on twelve non-distributed units.

FDANov 15, 2007Nationwide• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: Stryker Modular Replacement System Curved Cemented Stem; ...

Curvature Discrepancy -- The radius of curvature may be out of specification to varying degrees causing a discrepency in the stem curvature between trials and implants.

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FDANov 15, 2007Nationwide• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: Stryker COCR V40 Femoral Head; xx-Long (+16mm) Neck Lengt...

Fracture of Stem Neck - The firm recently performed laboratory testing indicates that there may be a potential increased risk of stem neck fractures when a V40 +16mm offset femoral head is mated with certain Accolade TMZF femoral stems in patients classified as overweight or obese.

FDANov 2, 2007Nationwide• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: Stryker LFIT COCR V40 Femoral Head; xx-Long (+16mm) Neck ...

FDANov 2, 2007Nationwide• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: Stryker Trial Head xx-Long (+16mm) Neck Length 26mm Diame...

FDANov 2, 2007Nationwide• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: UStryker Orthopaedics; HR Universal Bipolar Component; 26...

Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head.

FDAOct 26, 2007Nationwide• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: Stryker Orthopaedics, UHR Universal Bipolar Component; 26...

Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head.

FDAOct 26, 2007Nationwide• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: Hipstar V40 Femoral Stem-127 degrees; N degrees 3 high of...

Mis-labeling; The warning label "Do not use with heads more than +10mm offset" does not appear on 127 degree stem boxes.

FDASep 28, 2007Nationwide• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: Hipstar TMZF Cementless Hip Stem Protocol, Product Number...

Mis-labeling: An error on page 4 of the Hipstar protocol was found. In the table for compatible Heads, the 40 mm diameter heads with a Neck Length of +12 should have been omitted.

FDASep 28, 2007Nationwide• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: Hipstar V40 Femoral Stem-127 degrees; Catalog No: 7850-5-...

Mis-labeled: The warning label "Do not use with heads more than +10mm offset" does not appear on 127 degree stem boxes.

FDASep 28, 2007Nationwide• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: Stryker T2 Locking Screw, Fully threaded; 05 x 70mm, Cata...

Mislabeled: One lot of screws (05x70mm) is labeled as containing 70mm, but may actually contain 75mm length screws.

FDASep 27, 2007Nationwide• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: Stryker Orthopaedics PAL Pelvic Alignment Level, Ref: PAL...

The bubble in a vial of the Pelvic Alignment Level (PAL) was wider than the level marking. Upon opening the PAL and removing the vial, it was discovered that the vial was leaking

FDASep 11, 2007Nationwide• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: HA Solid Back Acetabular Shell; Arc Deposited HA Coated I...

Stryker Orthopaedics had identified that specific lots of Trident PSL Acetabular shells may have a dimensional discrepancy. The deviation regarding the difference in wall thickness will increase the gap between the shell and liner on one side and will decrease the gap between shell and liner on the opposing side, resulting in interference.

FDAAug 30, 2007Nationwide• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: Trident PSL HA Cluster Acetabular Shell; Arc Deposited HA...

FDAAug 30, 2007Nationwide• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: Howmedica Osteonics Corp., Scorpio NRG Femoral Size 7 Rig...

A box labeled as a Scorpio NRG Femoral Size 7 Right, may actually contain a Scorpio PS Femoral Size 5 Right.

FDAAug 20, 2007Nationwide• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: Triathlon X3 Total Stabilizer + Tibial Insert For use wi...

Stabilizer posts, packaged with the Triathlon TS Plus Tibial inserts have a specification anomaly related to length, resulting in a potential for the post to slightly protrude above the top surface of the plastic post.

FDAJul 31, 2007GA, IN, MN +2 more• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: Scorpio PS Femoral Waffle (No post) and LFIT; Use only wi...

Stryker Orthopaedics became aware that a box packaged and labeled as a Scorpio PS Femoral Waffle (No Post) with LFIT, may actually contain a Scorpio Femoral Waffle (With Post) and LFIT.

FDAJul 30, 2007Nationwide• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: Trident Hemispherical Acetabular Shell; 72mm, Arc Deposit...

Stryker Orthopaedics became aware that Trident Hemispherical Shells, Catalog Number 508-11-74J, are actually marked and labeled as Catalog Number 598-11-72J, Lot Code 20282301

FDAMay 29, 2007Nationwide• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: Omnifit EON Surgical Protocol; Literature Number: LSP48 4...

The Table 2 Broach and Neck Trial Sizing (Literature # LSP48 04/04) on page 3 is incorrect, reading 5mm less than what it should be for certain sizes.

FDAMay 17, 2007Nationwide• Stryker Howmedica Osteonics Corp.