Recalls / —
—#93503
Product
PERI-LOC (R), 3.5 MM ANTEROLATERAL DISTAL TIBIA PLATE, 10 HOLE, RIGHT - 148 MM, REF 71800710, QTY: (1), STERILE R, CE 0086, Smith & Nephew, Inc., Memphis, TN 38116, USA, EC REP: Smith & Nephew Orthopaedics Gmbh, Tuttlingen, Germany. Adult and pediatric patients, as indicated for pelvic, small, and long bone fracture fixation.
- FDA product code
- HRS — Plate, Fixation, Bone
- Device class
- Class 2
- Medical specialty
- Orthopedic
- 510(k) numbers
- K033669
- Affected lot / code info
- Lot number 08GM01779
Why it was recalled
Inner packaging of sterile product was not sealed. Lack of sterility assurance.
Root cause (FDA determination)
Packaging
Action the firm took
Smith & Nephew issued an "Urgent:: Medical Device Recall" letter dated July 20, 2010 to consignees (International distributors), identifying the issue and affected product. Consignees were requested to identify and quarantine affected stock, and cease distribution. Consignees were instructed to contact Smith and Nephew for a Return Authorization number. The Return Authorization number and an inventory of affected devices are to be recorded on the Verification Section of the notification letter and faxed to the firm. Affected stock is to be sent to Smith & Nephew. Consignees were requested to notify anyone to whom the product was distributed to also contact the firm for return of the product. Smith & Nephew can be contacted at 1-901-399-5441.
Recalling firm
- Firm
- Smith & Nephew Inc
- Address
- 1450 E. Brooks Rd, Memphis, Tennessee 38116
Distribution
- Distribution pattern
- Worldwide Distribution: INTERNATIONAL ONLY: Countries of China, UK, Italy, Australia, and South Africa
Timeline
- Recall initiated
- 2010-07-20
- Posted by FDA
- 2010-08-31
- Terminated
- 2011-11-17
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #93503. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.