The company said sutures inside the coil, which provide stretch resistance, may have been damaged during manufacturing and could lead to an occurrence of coil stretching.
Coil stretching during a procedure would require that the stretched coil be removed and replaced, and the most likely adverse event as a result is prolongation of the procedure.
Stryker said that there’s a “remote potential” of thrombus formation when the stretched coil is left in the blood flow, but there are no long term adverse health consequences post-removal.
The issue does not affect patients with implanted coils, Stryker clarified, and said the problem is a lot-specific manufacturing issue.
A total of 28 catalog numbers were included in the recall notice the company sent to customers with the affected products, with approximately 1,500 lots of items affected.
Stryker said it notified the FDA and other regulatory bodies of the issue, and that it has received 10 customer complaints related to the issue, but no adverse events have been reported.
Individuals with affected items were instructed to separate the affected units to return them to Stryker for replacement and to report any adverse events to the company.
Last August, Stryker recalled 16,992 orthopedic implant devices in an FDA Class II recall due to possible packaging compromises during transportation.
The units come from 5 different lines of products, with the FDA indicating the rHead, uHead, Sigmoid Notch, Remotion and Radio Capitellum devices for the recall.
Stryker began notifying customers in June of the issue, according to the FDA filing. The devices were distributed worldwide. The devices come from Small Bone Innovations, who Stryker purchased in October of 2014 for $375 million.