Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 16594 |
| Brand Name: | Acumed Tension Band Pin |
| Model: | TB-1550K-S TB-1570K-S TB-1590K-S |
| Affected: | Manufactured between Jan 2009 and March 2011 |
| Software version: | |
| Recalling Organisation: | Ortho Medics Limited 586 Great South Road Ellerslie Auckland 1051 |
| Contact Information: | 09 527 1203 |
| Manufacturer: | Acumed LLC |
| Issue: | This implantable product was manufactured wiht a grade of stainless steel that is different than from what was specified. Cytotoxicity tests confirm that product is NOT cytotoxic. Additional biocompatibility testing is currently underway. To date there have been no reported injuries and one malfunction with no harm to patient. The root cause of the malfunction is as yet inknown. |
| Recall action type: | Recall |
| Recall action: | Product to be returned to supplier |
| Level of recall: | Healthcare Professional |
| Date Commenced: | 28/4/2014 |
