—#125406

Product

Reflection Interfit Shell, 52 MM OD, 3 HOLE, REF 71336052, QTY 1, STERILE R, Smith & Nephew, Inc. Indications for use include cemented or uncemented total hip arthroplasty for rheumatoid arthritis; osteoarthritis; post traumatic arthritis, avascular necrosis; femoral and neck fractures; osteomyelitis; fracture, dislocation of the hip; and unsuccessful cup arthroplasty, endoprosthesis, femoral osteotomy, or girdlestone resection.

FDA product code: MBL — Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K960094
Affected lot / code info: Batch No. 13EM03053

Why it was recalled

Inner spherical radius of the shell is undersized.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Smith & Nephew Inc. sent an Urgent - Product Recall 1st Notification letter dated January 23, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. Actions for Hospital Representatives: 1. Please inspect your inventory and locate any unused devices from the above listed product and batch numbers, and quarantine them immediately. 2. Complete the last two columns in the Inventory Return Certification Form on the following page, indicating the quantities that need to be returned, and include your phone and fax number in the spaces provided. If you do not have product to return, please place an x in the column No product to return. 3. Please contact Smith & Nephews Safety Affairs Department via email at FieldActions@smith-nephew.com or fax +1-901-566-7975 to obtain a return authorization (RA) number. 4. Return any affected product to the address listed on the Inventory Return Certification Form. Please indicate the RA number on your return shipment. Actions for Smith & Nephew Inventory Specialists 1. Please inspect your inventory and locate any unused devices from the above listed product and batch numbers, cease distribution and use of those products, and quarantine them immediately. 2. Carry out a physical count of all affected product in your territory and record this data on the Inventory Return Certification Form on the following page. 3. If you do not have product to return, please place an x in the column No Product to Return, and then fill in the Acknowledgement of Responsibility at the bottom of the form. 4. Fax a copy of the completed Inventory Return Certification Form to: +1-901-566-7975 5. If you have affected products, return the product, along with the completed Inventory Return Certification Form, to the address indicated

Recalling firm

Firm: Smith & Nephew Inc
Address: 1450 E. Brooks Rd, Memphis, Tennessee 38116

Distribution

Distribution pattern: Worldwide Distribution: US Distribution to NJ and FL; and the countries of: Colombia and Costa Rica.

Timeline

Recall initiated: 2014-01-23
Posted by FDA: 2014-02-21
Terminated: 2016-11-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #125406. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.