—#78775

Product

Accolade TMZF Hip Stem; Hydroxylapatite Coated, Titanium Plasma Spray, V40 Taper, Sterile. 132 degree neck angle. Hip stems are single use devices intended for cementless fixation. The products are intended for use in primary reconstruction of the proximal femur or revision of a previous total hip arthroplasty.

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: K020572
Affected lot / code info: 6020-0335 ACCOLADE 132 SIZE 3 24972401 6020-0335 ACCOLADE 132 SIZE 3 25004402 6020-0335 ACCOLADE 132 SIZE 3 25045302 6020-0335 ACCOLADE 132 SIZE 3 25045303 6020-0335 ACCOLADE 132 SIZE 3 25107804 6020-0335 ACCOLADE 132 SIZE 3 25178601 6020-0335 ACCOLADE 132 SIZE 3 25230801 6020-0335 ACCOLADE 132 SIZE 3 25230802 6020-0335 ACCOLADE 132 SIZE 3 25245502 6020-0335 ACCOLADE 132 SIZE 3 25245503 6020-0335 ACCOLADE 132 SIZE 3 25255101 6020-0335 ACCOLADE 132 SIZE 3 25274002 6020-0335 ACCOLADE 132 SIZE 3 25348901 and 6020-0335 ACCOLADE 132 SIZE 3 25386101.

Why it was recalled

Product deviation : Specific lots of sprayed HA hip stems did not meet Stryker's Internal Material Specification for tensile bond strength and crystallinity.

Root cause (FDA determination)

Process control

Action the firm took

An "Urgent Product Recall" letter was sent via Federal Express on January 6, 2009 with return receipt to Stryker Branches/Agencies, Hospital Risk Management, Hospital Chief of Orthopaedics and Surgeons. The letter described the affected product, issue, potential hazards and risks. Stryker Branches and Hospital Risk Management were asked to examine their inventory for affected product. Stryker Representatives were instructed to contact customers to reconcile and return recalled product to Stryker Orthopaedics. All letters include a response form to be completed and returned indicating that they have been informed of the recall and the amount of product on hand, if any. Direct questions about the recall to Stryker Orthopaedics at 1-201-831-5718.

Recalling firm

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

Distribution

Distribution pattern: Nationwide Distribution.

Timeline

Recall initiated: 2009-01-06
Posted by FDA: 2009-07-22
Terminated: 2012-06-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #78775. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.