Retiro De Equipo (Recall) de DELTA XTEND Reverse Shoulder System Modular Centered and Eccentric Epiphysis ImplantsModular Centered Epiphysis Size 1 HAModular Eccentric Epiphysis Size 1 Left HAModular Eccentric Epiphysis Size 1 Right HAModular Centered Epiphysis Size 2 HAModular Eccentric Epiphysis Size 2 Left HAModular Eccentric Epiphysis Size 2 Right HA

Recall

RC-2017-RN-01218-1

Class II

2017-09-21

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01218-1

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.

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.