Recall Z-0405-2020 ยท PHX Shoulder Prosthesis, Reverse Configuration
Tornier, Inc
Aequalis Ascend Flex Humeral Stem: Part Number UDI DWF601A 3700386944475 DWF601B 3700386944482 DWF601C 3700386944499 DWF602A 3700386944505 DWF602B 3700386944512 DWF602C 3700386944529 DWF603A 3700386944536 DWF603B 3700386944543 DWF603C 3700386944550 DWF604A 3700386944567 DWF604B 3700386944574 DWF605A 3700386944598 DWF605B 3700386944604 DWF605C 3700386944611 DWF606A 3700386944628 DWF606B 37003869446
| Date | Oct 18, 2019 |
| Status | Terminated |
| Reason | During shipping, it is possible for the Aequalis Ascend Flex humeral stem to become unseated or otherwise move within its internal packaging restraints. Movement within the packaging may cause the product to rub against the PETG blister shipping container causing the transfer of PETG material from the blister container to the stem. |
| Root cause | Package design/selection |
| Action | The firm notified their consignees by letter on 10/18/2019. The notices explained the issue and requested the following: Please undertake the following urgent actions when using Aequalis Ascend Flex humeral stems: " Ensure backup stem product is available in the operating room or is easily accessible prior to beginning surgery. " Visually examine the stem after removing the stem from its packaging. " If white film or particles are seen on the stem as pictured in Attachment A, immediately remove the implant and anything it touches from the sterile field. Replace the stem with a backup st |
| Quantity | 87869 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K122698 | AEQUALIS ASCEND FLEX SHOULDER SYSTEM Tornier S.A.S., Jan 8, 2013 |