Stryker Orthopaedics Tapers LFIT V40 Vitallium femoral heads. hip prosthesis component.
- Recall Initiated
- September 8, 2015
- Posted
- November 10, 2015
- Terminated
- July 25, 2017
- Recall Number
- Z-0261-2016
- Quantity
- 201
- Firm Location
- Mahwah, NJ
Reason for Recall
Complaints that the femoral head could not be assembled with its corresponding V40 stem trunnion at the time of surgery.
Distribution
Nationwide Distribution
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
Root Cause
Process design
Action Taken
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.