Z-1020-2012

DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 54mm GROUP E, REF DSBFGE54, Rx ONLY, STERILE R, Wright Medical Technology...

Name: Z-1020-2012 DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 54mm GROUP E, REF DSBFGE54, Rx ONLY, STERILE R, Wright Medical Technology...
Creator: Wright Medical Technology Inc
Published: 2012-01-03
License: https://open.fda.gov/license/

Wright Medical Technology Inc / initiated 2012-01-03 / Terminated / root cause: packaging

FDA source

Wright Medical Technology Inc began a recall of DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 54mm GROUP E, REF DSBFGE54, Rx ONLY, STERILE R, Wright Medical Technology, Inc., hip prosthesis acetabular component. The... on 2012-01-03. The reason FDA records is "The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted into a patient and could potentially lead to complications that might necessitate a revision surgery". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1020-2012
Status: Terminated
Initiated: 2012-01-03
Posted: 2012-02-14
Terminated: 2013-03-13
Recalling firm: Wright Medical Technology Inc
Product: DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 54mm GROUP E, REF DSBFGE54, Rx ONLY, STERILE R, Wright Medical Technology, Inc., hip prosthesis acetabular component. The instrument is used as a hip acetabular shell.
Product code: KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
Reason for recall: The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted into a patient and could potentially lead to complications that might necessitate a revision surgery.
Root cause tag: packaging
FDA root cause: Packaging
Action: Wright Medical sent an "URGENT PRODUCT RECALL NOTIFICATION" letter dated December 27, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to check their inventory for the affected product and to return any affected product to the firm. A Product Recall Verification Form was enclosed for customers to complete and return via fax to 901-867-7401. Contact Customer Service at 1-800-238-7117 for questions regarding this recall.
Quantity in commerce: 939 units
Distribution: Worldwide Distribution-USA (nationwide) and the countries of Australia, Brazil, Canada, Denmark, and Italy.
Product codes and lots: Lot Numbers: 1373323, 1373324, 1373325, 1374842, 1378891, 1381021, 1381022, 1381023, 1388095, 1393853, 1393854, 1400101, 1401174, 1404092, 1405127, 010968478, 010973155, 020988034, 079868619, 089876863, 0111225746, 0111235664, 0111241004, 119935686, 129941901, 129965094, 129966048, 0201012354, 0201018596, 0211247698, 0211260213, 0211286115, 0401036850, 0411321263, 0411321264, 0411327743, 0411327744, 0501027020, 0501045918, 0501095719, 0511336663, 0511336664, 0511344244, 0511344245, 0601125075, 0611373991, 0611373992, 0611377759, 0611380738, 0701148277, 0711364803, 0711364804, 0711369706, 0711369707, 0711369708, 0711380724, 0801144253, 0801148528, 0801150047, 0801158943, 0801165303, 0801170860, 0801178540, 0801184424, 1001186476, 1001189885, 1001197060, 1101200099, 1201210358, 1201211102, 1201216628, 05984260810, 070114136401

Product code KWA

K082924Class IIIDynasty Porous Acetabular Shell, Dynasty Polyethylene Acetabular Liner, Dynasty Metal Acetabular LinerWrightmedicaltechnologyinc / cleared 2009-03-06

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)