Z-0699-2017Class II

Aequalis Fx2 implant parts and instrument trays. Insert component : Part Numbers DWK204B-DWK206B...

Name: Z-0699-2017 Aequalis Fx2 implant parts and instrument trays. Insert component : Part Numbers DWK204B-DWK206B...
Creator: Tornier, Inc
Published: 2016-09-19
License: https://open.fda.gov/license/

TORNIER Inc. / initiated 2016-09-19 / Terminated / root cause: design

FDA source

Tornier, Inc began a recall of Aequalis Fx2 implant parts and instrument trays. Insert component : Part Numbers DWK204B-DWK206B, DWK224B-DWK226B, DWK230B-DWK23B, DWK244B-DWK246B... on 2016-09-19. FDA classified it as Class II and gives the reason as "Tornier is conducting a recall on Aequalis Fx2 ( implant parts and instrument trays) due to reports of dislocations of the poly insert and the stem". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0699-2017
Classification: Class II
Status: Terminated
Initiated: 2016-09-19
Posted: 2016-12-03
Terminated: 2018-05-31
Recalling firm: TORNIER Inc.
Product: Aequalis Fx2 implant parts and instrument trays. Insert component : Part Numbers DWK204B-DWK206B, DWK224B-DWK226B, DWK230B-DWK23B, DWK244B-DWK246B, DWK250B-DWK252B, DWK264B-DWK266B, DWK270B-DWK272B. Stem Component: Part Number: DWK111B-DWK115B, DWK121B-DWK126B, DWK131B-DWK135B. Product Usage: Total or partial replacement of the Gleno-humeral articulation.
Product code: KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Reason for recall: Tornier is conducting a recall on Aequalis Fx2 ( implant parts and instrument trays) due to reports of dislocations of the poly insert and the stem.
Root cause tag: design
FDA root cause: Component design/selection
Action: Wright sent an "Urgent Medical Device Recall" letter dated September 19, 2016. The letter was addressed to Healthcare Professional. The letter identified the affected product, problem and actions to be taken. It advised consignees to stop further distribution or use of product immediately. Requires consignees to notify all accounts that may be end-users, or contact Wright with your request for us to contact them. Advised consignee to complete and e-mail the attached questionnaire to [email protected]. For questions contact the same.
Quantity in commerce: 30
Distribution: US Distribution TX, CA, and MI
Product codes and lots: 0924AR, 0809AR, 1110AR, 1290AR, 0811AR, 0151AR, 2447AR, 6082AQ, 5935AQ, 6373AQ, 7153AQ, 7532AQ, 9966AQ, 0018AQ, 0385AR, 0386AR, 0384AR, 3014AR, 6892AQ, 8250AQ, 6893AQ, 6924AQ, 8249AQ, 6853AQ, 6925AQ, 6962AQ, 8795AQ, 8210AQ, YKAD241, YKAD244.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0699-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0699-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-14	2016-12-02

Product code KWS

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)