Calaxo® Bone Screw Update

Manufactured by Smith & Nephew, the Calaxo® screw (officially known as the Calaxo Bioabsorbable Interference Screw) was approved by the FDA and first made available for use in the U.S. in March of 2006. As soon as the screw began to be used in ACL (anterior cruciate ligament) knee surgery, reports began to come in about the Calaxo® screws breaking inside the body and causing severe knee pain.

The last FDA word on the Calaxo® Screw was in the March 26, 2008 FDA Weekly Enforcement Report. In it the FDA details the recall under RECALLS AND FIELD CORRECTIONS: DEVICES – CLASS II.

Here follows the FDA Enforcement Report for March 26, 2008:

Enforcement Report
The FDA Enforcement Report is published weekly by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.

PRODUCT
Smith & Nephew, CALAXO Bioabsorbable lnterference Screw (all the different sizes detailed)
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Smith & Nephew, Inc., Endoscopy Division, Andover, MA, by letter on August 21 and August 23, 2007.
Manufacturer: Smith & Nephew, Inc., Endoscopy Division, Mansfield, MA. Firm initiated recall is ongoing.
REASON
Patient Reaction: Post operative condition sterile fluid pocket has been identified, including the potential for graft failure and premature material degradation.
VOLUME OF PRODUCT IN COMMERCE
68,285 units
DISTRIBUTION
Nationwide and Internationally

Comments on the listing above
In this short listing, the story is told. The manufacturer, Smith & Nephew, Inc, and the Endoscopy manufacturing division, located in Mansfield, MA, initiated a recall by letter on August 21 and then again on August 23, 2007. The company itself initiated the recall and the recall is ongoing.

Three reasons for the recall are given here:

First is mention of a post operative fluid pocket, fluid that in some cases built up in the body reaction to the implanted screw after surgery.

Additionally listed is “the potential for graft failure”, which could be talking about the side effect of infected or dead tissue or bone that has to be surgically removed (a process known as debridement).

The final mentioned reason, “premature material degradation”, means that in some cases the screws broke into pieces and had to be surgically removed

The number of units recalled is now known to be exactly 68,285 units.

The final note was that the Calaxo screw had been distributed both nationally and internationally – there is no mention of what other countries might have been affected, or what proportion of screws were distributed in the US versus abroad.

In any case, if you have reason to suspect that you or a loved one were implanted with one of these Calaxo Bioabsorbable Interference Screws in ACL surgery, surgery that almost certainly took place between March 2006 and November 2007, you may be entitled to compensation.

Contact Eric Gruenwald, Attorney / Lawyer at (866) 529-0001, EXT. 245, or by email at help@mulliganlaw.com for a free consultation.

Leave a Reply