Important Safety Alerts

The Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom posted a medical device safety alert concerning Sterile & Non-Sterile Individually Packaged BOLD 2.5 Compression Screw, manufactured by Newdeal SAS, a company within Integra LifeSciences Group. The affected catalog numbers are 200010, 200010S, 200016 and 200016S. Batches F9SP and FAGJ are involved.

The manufacturer has recently identified that some screws from one batch of BOLD 2.5 Compression Screw, Length 16 mm (Catalog number 200016 – batch FAGJ) have been packaged and labeled with the specifications of BOLD 2.5 Compression Screw, Length 10mm (Catalog number 200010 – batch F9SP). As a consequence:

• If a shorter screw was inadvertently used based on the labeling, the screw might not have enough threads to engage intended structures resulting in inadequate fixation or reconstruction.
• If a longer screw was inadvertently used based on the labeling, the shaft or tip of the screw might penetrate unintended structures (bone, vessel, tissue), resulting in damage to those structures.

The manufacturer has made a decision to conduct a voluntary recall of the two batches.

For details, please refer to the MHRA websites:https://www.gov.uk/government/publications/safety-information-from-manufacturers-field-safety-notices/field-safety-notices-26-to-30-october-2015

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 3 November 2015