| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01218-1 |
| Product Name/Description |
DELTA XTEND Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants
Modular Centered Epiphysis Size 1 HA
Modular Eccentric Epiphysis Size 1 Left HA
Modular Eccentric Epiphysis Size 1 Right HA
Modular Centered Epiphysis Size 2 HA
Modular Eccentric Epiphysis Size 2 Left HA
Modular Eccentric Epiphysis Size 2 Right HA
Multiple Part and Lot Numbers
ARTG Number: 143529 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
21/09/2017 |
| Responsible Entity |
|
| Reason/Issue |
An investigation by Johnson & Johnson Medical determined that certain lots produced in a specific machine were manufactured in a manner in which the post’s diameter is out-of-specification. Further investigation determined that the issue is related to the circularity of the cylinder. The circularity issue may cause the epiphysis to interfere with the stem and the two implants (epiphysis and stem) cannot be assembled. Six (6) complaints were received worldwide within approximately a one month period. The current complaint rate associated with this failure mode is 0.0260%.
If the epiphysis does not assemble to the stem and an alternative device is available, there may be a surgical delay of 15 to 59 minutes.
Or, if an alternative implant is not available, the patient’s wound may need to be closed and the patient scheduled for a reoperation when a suitable device is available.
Note: Once the epiphysis is properly assembled to the stem, there is no additional risk to the patient. |
| Recall Action |
Recall |
| Recall Action Instructions |
1. Users are to inspect the device(s) in your possession to determine if they possess affected product. If so quarantine this product prior to returning it to JJM. Return a copy of the supplied completed acknowledgement form as directed.
2. Return any affected product within 30 business days, by contacting JJM Customer Service on 1300 562 711. You may wish to request assistance from your JJM DePuy Synthes Representative.
3. Forward this notice to anyone in your facility who needs to be informed.
4. If any potentially affected product(s) has been forwarded to another facility, contact that facility to arrange inspection and return (if applicable).
5. Keep a copy of the customer letter until actions are completed.
6. JJM will also write to implanting surgeons to advise them of this and the non-risk it presents to implanted devices.
This action has been closed out on the 25/06/2019.
This action has been closed out on 25/06/2019 |
| Contact Information |
1300 562 711 - JJM Customer Service |