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 Recall Z-2297-2016 · Posted 2016-07-28
Advertisement
Recalling FirmSmith & Nephew, Inc.
Recall StatusTerminated
Product CodeMEH
Date Initiated2016-07-06
Date Terminated2017-07-01
Product Quantity185 units
Reason for Recall
The labels correctly state that the product should be a 25mm screw, but the box contained a longer, 35mm screw.
Firm Action
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 [email protected] to obtain a return authorization (RA) number.
For questions regarding this recall call 901-399-5520.
Root Cause
Packaging process control
Distribution Pattern
Worldwide Distribution - US (nationwide) and Internationally to AU, CA, GB, IN, ZA, and TR
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement