Skip to content

PERI-LOC (R), 3.5 MM ANTEROLATERAL DISTAL TIBIA PLATE, 10… recallZ-2314-2010 · Smith & Nephew Inc · initiated Jul 20, 2010

Terminated All recalls posted in August 2010

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Smith & Nephew Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Inner packaging of sterile product was not sealed. Lack of sterility assurance.

FDA root cause category: Packaging

What the company is doing

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.

Recall details

Recall number
Z-2314-2010
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Jul 20, 2010
Posted by the FDA
Aug 31, 2010
Recalling firm
Smith & Nephew Inc
Quantity
10 units
Product code
HRS
FDA submissions
K033669
Distribution
Worldwide Distribution: INTERNATIONAL ONLY: Countries of China, UK, Italy, Australia, and South Africa

Product description

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.

Code information (models, lots, serial numbers)

Lot number 08GM01779

Other devices under the same FDA submission

13 devices cleared under K033669 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page