| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00463-1 |
| Product Name/Description |
SwiveLock SP Suture Anchor
Product Codes: AR-2323BSLM, AR-2323PSLM, AR-2324BCM, AR-2324PSLM, AR-2600SBS-5, AR-2600SBS-7
Multiple Products and Batch Numbers
ARTG Numbers: 126657 and 164046 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
18/04/2017 |
| Responsible Entity |
|
| Reason/Issue |
It has been determined that there is an issue with specific batches of the self-punching eyelet contained within the Arthrex SwiveLock SP Suture Anchor which may cause the eyelet to break on insertion in hard bone.
Please note that there is no impact to the patient if the device has been implanted successfully. |
| Recall Action |
Recall |
| Recall Action Instructions |
Device Technologies Australia (DTA) is requesting users to immediately discontinue use of the affected devices and to inform all relevant personnel at their facility of the recall notice. Users are further requested to quarantine their affected stock and return a completed Reply Fax Form, advising the quantity of affected stock. Users are advised that credit will be issued upon DTA's receipt of the returned items.
This action has been closed-out on 26/03/2018. |
| Contact Information |
02 9972 8339 – Device Technologies |