—#148051

Product

SPHERICAL HEAD REFLECTION(R) 6.5 MM CANCELLOUS SCREW, REF 71332525, QTY: (1), STERILE R, smith&nephew Total hip components are indicated for individuals undergoing primary or revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant; congenital dysplasia; old, remote osteomyelitis with an extended drainage-free period, nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity.

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: K990666
Affected lot / code info: Lot Number 16AM14274

Why it was recalled

The labels correctly state that the product should be a 25mm screw, but the box contained a longer, 35mm screw.

Root cause (FDA determination)

Packaging process control

Action the firm took

Smith & Nephew sent an Urgent Product Recall Notification letter dated July 6, 2016, to all affected consignees via email and FedEx Overnight delivery on July 6, 2016. The letter identified the product, the problem, and the action to be taken by the consignee. Customers were asked to inspect their inventory and located any unused affected devices and quarantine them immediately, complete the Inventory Return Certification Form and fax to 1-901-566-7975 indicating the quantities that need to be returned. Consignees should contact Smith & Nephew's Field Actions Department via email at FieldActions@smith-nephew.com to obtain a return authorization (RA) number. For questions regarding this recall call 901-399-5520.

Recalling firm

Firm: Smith & Nephew, Inc.
Address: 1450 E Brooks Rd, Memphis, Tennessee 38116-1804

Distribution

Distribution pattern: Worldwide Distribution - US (nationwide) and Internationally to AU, CA, GB, IN, ZA, and TR

Timeline

Recall initiated: 2016-07-06
Posted by FDA: 2016-07-28
Terminated: 2017-07-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #148051. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.