—#140496

Product

Stryker Orthopaedics Tapers LFIT V40 Vitallium femoral heads. hip prosthesis component.

FDA product code: LPH — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K121308
Affected lot / code info: Catalog Numbers 6260-5-028; 6260-5-032; 6260-5-132; 6260-5-232, 232; 6260-5-328; 6260-5-332; 6260-5-428; 6260-5-432; 6260-9-0928; 6260-9-032, 6260-9-132, 6260-9-232, 6260-9-328, 6260-9-332, 6260-9-428, 6280-0-128, 6280-0-228, 6280-0-232, 6280-0-332 exp- dates july 2019 to august 2019

Why it was recalled

Complaints that the femoral head could not be assembled with its corresponding V40 stem trunnion at the time of surgery.

Root cause (FDA determination)

Process design

Action the firm took

Stryker sent an Urgent Medical Device Recall Notifiications dated September 9 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers are asked to complete the attached form and return within 5 days by using email strykerortho6632@stericycle.com or FAX 1-888-965-5803. For further questions please call ( 201) 831-5000.

Recalling firm

Firm: Stryker Howmedica Osteonics Corp.
Address: 325 Corporate Dr, Mahwah, New Jersey 07430-2006

Distribution

Distribution pattern: Nationwide Distribution

Timeline

Recall initiated: 2015-09-08
Posted by FDA: 2015-11-10
Terminated: 2017-07-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #140496. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.