Recall Z-1982-2012— Stryker Howmedica Osteonics Corp.

Name: FDA recall Z-1982-2012
Creator: U.S. Food and Drug Administration
Published: 2011-12-29

Class II · Terminated

Class II FDA medical device recall by Stryker Howmedica Osteonics Corp., initiated 2011-12-29, terminated 2015-03-19. It names one FDA 510(k) clearance: K936127. Product: Stryker Orthopaedics, Definition PM Femoral Hip Stem Catalog Numbers 6265-3-099 through 6265-3-107. Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430. A subsidiary of Stryker Corp. Stryker France, ZAC Satorlas Green Pusignan, Av De Satolas Green 69881 Meyzeiu, Cedex France. Made in Ireland. The Definition PM femoral hip stem is a forged, collared, straight stem with an integral premantle (PM) design. The Poly Methyl Methacrylate (PMMA) and Barium Sulphate (BaSO4) premantle is integral to the design as it aligns, centralizes and pressurizes the stem within the femoral canal. The forged stem is first grit blasted proximally and then the premantle is applied through an infection molding process.. Reason: Stryker Orthopaedics has become aware of the potential for cracking of the PMMA coating on their PM COCR Hip Stem product..

Recalling firm: Stryker Howmedica Osteonics Corp.
Classification: Class II
Status: Terminated
Initiated: 2011-12-29
Terminated: 2015-03-19
Firm location: Mahwah, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K936127 — HOWMEDICA PREMIUM FEMORAL COMPONENTHowmedica, Inc.·cleared 1994-10-26

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Stryker Orthopaedics, Definition PM Femoral Hip Stem Catalog Numbers 6265-3-099 through 6265-3-107. Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430. A subsidiary of Stryker Corp. Stryker France, ZAC Satorlas Green Pusignan, Av De Satolas Green 69881 Meyzeiu, Cedex France. Made in Ireland. The Definition PM femoral hip stem is a forged, collared, straight stem with an integral premantle (PM) design. The Poly Methyl Methacrylate (PMMA) and Barium Sulphate (BaSO4) premantle is integral to the design as it aligns, centralizes and pressurizes the stem within the femoral canal. The forged stem is first grit blasted proximally and then the premantle is applied through an infection molding process.

Reason for recall

Stryker Orthopaedics has become aware of the potential for cracking of the PMMA coating on their PM COCR Hip Stem product.

Data sourced from openFDA. This site is unofficial and independent of the FDA.