—#106863

Product

DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 56mm GROUP F, REF DSBFGF56, Rx ONLY, STERILE R, Wright Medical Technology, Inc., hip prosthesis acetabular component. The instrument is used as a hip acetabular shell.

FDA product code: KWA — Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
Device class: Class 3
Medical specialty: Orthopedic
510(k) numbers: K082924
Affected lot / code info: Lot Numbers: 842609, 1373327, 1374836, 1374841, 1378885, 1378886, 1378887, 1388096, 1388098, 1393855, 1401332, 1405228, 1405233, 010969761, 010973158, 020976449, 020983750, 020998829, 079874283, 099907007, 0111200104, 0111225803, 0111241005, 119928418, 119932054, 119934132, 129937587, 129958770, 129966049, 0201010185, 0201016141, 0211216629, 0211235666, 0211247704, 0211256648, 0211275871, 0311291336, 0311295433, 0401027672, 0401047122, 0401051291, 0401082870, 0501102207, 0501112341, 0511344246, 0511344247, 0601125076, 0611373193, 0611380773, 0701148278, 0711361483, 0711361484, 0711361485, 0711373326, 0711373328, 0711380787, 0711381258, 0801144282, 0801146267, 0801148529, 0801150054, 0801158944, 0801165304, 0801178541, 0801184425, 1101189886, 1101210360, 1101211103, 1101220321, 05983592110

Why it was recalled

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 (FDA determination)

Packaging

Action the firm took

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.

Recalling firm

Firm: Wright Medical Technology Inc
Address: 5677 Airline Rd, Arlington, Tennessee 38002-9501

Distribution

Distribution pattern: Worldwide Distribution-USA (nationwide) and the countries of Australia, Brazil, Canada, Denmark, and Italy.

Timeline

Recall initiated: 2012-01-03
Posted by FDA: 2012-02-14
Terminated: 2013-03-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #106863. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.