| Date Initiated by Firm |
October 18, 2019 |
| Create Date |
November 14, 2019 |
| Recall Status1 |
Terminated 3 on April 09, 2021 |
| Recall Number |
Z-0405-2020 |
| Recall Event ID |
84033 |
| 510(K)Number |
K122698
|
| Product Classification |
shoulder prosthesis, reverse configuration - Product Code PHX
|
| Product |
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 3700386944635
DWF606C 3700386944642
DWF607A 3700386944659
DWF607B 3700386944666
DWF607C 3700386944673
DWF608A 3700386944680
DWF608B 3700386944697
DWF608C 3700386944703
DWF609A 3700386944710
DWF609B 3700386944727
DWF609C 3700386944734
DWF611A 3700386944741
DWF611B 3700386944758
DWF611C 3700386944765
DWF612A 3700386944772
DWF612B 3700386944789
DWF612C 3700386944796
DWF613A 3700386944802
DWF613B 3700386944819
DWF613C 3700386944826
DWF614A 3700386944833
DWF614B 3700386944840
DWF614C 3700386944857
DWF615A 3700386944864
DWF615B 3700386944871
DWF615C 3700386944888
DWF616A 3700386944895
DWF616B 3700386944901
DWF616C 3700386944918
DWF617A 3700386944925
DWF617B 3700386944932
DWF617C 3700386944949
DWF618A 3700386944956
DWF618B 3700386944963
DWF618C 3700386944970
DWF619A 3700386944987
DWF619B 3700386944994
DWF619C 3700386945007
DWF702A 3700386945045
DWF702B 3700386945052
DWF702C 3700386945069
DWF703A 3700386945076
DWF703B 3700386945083
DWF703C 3700386945090
DWF704A 3700386945106
DWF704B 3700386945113
DWF704C 3700386945120
DWF705A 3700386945137
DWF705B 3700386945144
DWF705C 3700386945151
DWF706A 3700386945168
DWF706B 3700386945175
DWF706C 3700386945182
DWF707A 3700386945199
DWF707B 3700386945205
DWF707C 3700386945212
DWF708A 3700386945229
DWF708B 3700386945236
DWF708C 3700386945243
DWF709A 3700386945250
DWF709B 3700386945267
DWF709C 3700386945274
DWF712A 3700386945311
DWF712B 3700386945328
DWF712C 3700386945335
DWF713A 3700386945342
DWF713B 3700386945359
DWF713C 3700386945366
DWF714A 3700386945373
DWF714B 3700386945380
DWF714C 3700386945397
DWF715A 3700386945403
DWF715B 3700386945410
DWF715C 3700386945427
DWF716A 3700386945434
DWF716B 3700386945441
DWF716C 3700386945458
DWF717A 3700386945465
DWF717B 3700386945472
DWF717C 3700386945489
DWF718A 3700386945496
DWF718B 3700386945502
DWF718C 3700386945519
DWF719A 3700386945526
DWF719B 3700386945533
DWF719C 3700386945540
Product Usage: The AEQUALIS ASCEND FLEX Convertible Shoulder System is intended for use as: A replacement of shoulder joints in primary anatomic or primary reverse. A replacement of other shoulder joint devices in case of revisions, if sufficient bone stock remains. The AEQUALIS ASCEND FLEX Convertible Shoulder System also allows for conversions from anatomic to reverse shoulder prosthesis in case of revision. |
| Code Information |
All Lot/Serial Numbers |
Recalling Firm/
Manufacturer |
Tornier, Inc
10801 Nesbitt Ave S
Bloomington MN 55437-3109
|
| For Additional Information Contact |
Darren Brown
952-426-7625
|
Manufacturer Reason
for Recall |
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.
|
FDA Determined
Cause 2 |
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 stem that lacks visible white film or particles.
" If no packaging material is visible on the stem, you may proceed with the implantation procedure.
" Report the discovery of any stems with packaging material to Wright Medical.
" Contact customer service to facilitate the return and replacement of any affected product
o Customer Service Customer.service@Wright.com, or 1-888-494-7950
o Return product to Wright Medical, 10801 Nesbitt Ave S, Bloomington, MN 55437
o Please identify that this product and issue is related to Field Action FA-WMG-2019-005
Please contact the following for information:
Customer service Customer.service@Wright.com (replacements, product support)
Field Action Team FieldAction@Wright.com (more information on this notice)
Complaints Team Complaints-US@Wright.com (If product is found to be non-conforming) |
| Quantity in Commerce |
87869 units |
| Distribution |
US Nationwide distribution. |
| Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
| 510(K) Database |
510(K)s with Product Code = PHX and Original Applicant = Tornier SAS
|
