Recalls / —

—#78918

Product

Stryker Howmedica Osteonics, Super SecurFit HA Hip Stem; Sterile Arc Deposited, V40 taper Not for use with 16mm heads.

FDA product code

MEH — Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate

Device class

Class 2

Medical specialty

Orthopedic

510(k) numbers

K020615

Affected lot / code info

Catalog numbers: J6051-0425, J0651-0525, J6051-0625. All lot codes with an expiry prior to Aug. 2013.

Why it was recalled

Stryker Orthopaedics became aware that there may be difficulty in mating stem to implantation/extraction instrument.

Root cause (FDA determination)

Device Design

Action the firm took

Stryker sent Urgent product Correction Letters on January 14, 2009 by Federal Express to Stryker branches/agencies, hospital risk management, chief of orthopaedics and surgeon.

Recalling firm

Firm

Stryker Howmedica Osteonics Corp.

Address

325 Corporate Dr, Mahwah, New Jersey 07430

Distribution

Distribution pattern

Nationwide. Product was distributed to 3 Stryker branches/agencies and 2 hospitals in PA and CA.

Timeline

Recall initiated

2009-01-14

Posted by FDA

2009-12-22

Terminated

2012-07-18

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #78918. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.