| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00353-1 |
| Product Name/Description |
Oscillating Saw Attachment for Colibri/Colibri II Small Electric Drive
(Battery-driven, cutting power tool system used in surgical procedures such as cutting of bone and hard tissue)
Part Number (Saw Attachment): 532.021
All Serial Numbers
Product Numbers (Electric Drive): 532.001, 532.010, 532.101, 532.110 and 05.001.175
ARTG number: 157072 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
23/04/2015 |
| Responsible Entity |
|
| Reason/Issue |
Johnson & Johnson Medical Pty Limited (JJM) has received reports that the Oscillating Saw Attachment may disengage intra-operatively.
If the device is tested in the operative theatre and the unit does not function, the user most likely would discontinue use of the affected part, and a replacement Oscillating Saw Attachment would be procured, which may lead to surgical delay. Injury to the patient can occur if the Attachment disengages intra-operatively. There is also a potential of injury to the user from the sharp edge of the subject Oscillating Saw during retrieval. One report of a serious injury was received where the part fell apart during surgery and resulted in cuts in the hand of a user. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Johnson & Johnson Medical Pty Limited (JJM) is providing instructions to customers for checking for any disassembly of the attachment as part of every reprocessing cycle. If customers notice any disassembly of the attachment or are able to unscrew the attachment as part of the inspection, they are advised to not use it and immediately send it for repair. Devices which perform satisfactorily during the inspection may be used as intended. A review and repair will be implemented if necessary during the next scheduled maintenance inspection at the Service Centre. Customers are also reminded to ensure the devices are sent for maintenance according to the recommended annual schedule.
This action has been closed out on 25/10/2018 |
| Contact Information |
1800 252 194 - Johnson & Johnson Medical |