Smith and Nephew Oxinium Genesis II and Profix Knee Recall

FDA Warning: Smith & Nephew recall of Journey Base Plates

Mar 17, 2010: Smith & Nephew recalls Journey BASE PLATES; int.
Manufacturer: Smith & Nephew, Inc., Memphis, TN
Product: Medicals
Start Date: 2010-03-17
End Date: 2010-04-17

PRODUCTS

1) JOURNEY " UNI TIBIAL BASEPLATE, LEFT MEDICAL/TIGHT LATERAL, A/P 38 MM, M/L 24 MM, REF 71422221, FOR CEMENTED USE ONLY, QTY: (1), STERILE. Recall # Z-0924-2010;

2) JOURNEY " UNI TIBIAL BASEPLATE, LEFT MEDIAL/RIGHT LATERAL, A/P 42 MM, M/L 25 MM, REF 71422222, FOR CEMENTED USE ONLY, QTY: (1), STERILE R. Recall # Z-0925-2010;

3) JOURNEY " UNI TIBIAL BASEPLATE, LEFT MEDIAL/RIGHT LATERAL, A/P 46MM, M/L 27 MM, REF 71422223, FOR CEMENTED USE ONLY, QTY: (1), STERILE R. Recall # Z-0926-2010;

4) JOURNEY " UNI TIBIAL BASEPLATE, LEFT MEDIAL/RIGHT LATERAL, A/P 49 MM, M/L 29 MM, REF 71422224, FOR CEMENTED USE ONLY, QTY: (1), STERILE R. Recall # Z-0927-2010;

5) JOURNEY " UNI TIBIAL BASEPLATE, LEFT MEDIAL/RIGHT LATERAL, A/P 52 MM, M/L 30 MM, REF 71422225, FOR CEMENTED USE ONLY, QTY: (1), STERILE R. Recall # Z-0928-2010;

6) JOURNEY " UNI TIBIAL BASEPLATE, LEFT MEDIAL/RIGHT LATERAL, A/P 55 MM, M/L 32 MM, REF 71422226, FOR CEMENTED USE ONLY, QTY: (1), STERILE R. Recall # Z-0929-2010;

7) JOURNEY " UNI TIBIAL BASEPLATE, RIGHT MEDIAL/LEFT LATERAL, A/P 42 MM, M/L 25 MM, REF 71422232, FOR CEMENTED USE ONLY, QTY: (1), STERILE R. Recall # Z-0930-2010;

8) JOURNEY " UNI TIBIAL BASEPLATE, RIGHT MEDIAL/LEFT LATERAL, A/P 46 MM, M/L 27 MM, REF 71422233, FOR CEMENTED USE ONLY, QTY: (1), STERILE R. Recall # Z-0931-2010;

9) JOURNEY " UNI TIBIAL BASEPLATE, RIGHT MEDIAL/LEFT LATERAL, A/P 49 MM, M/L 29 MM, REF 71422234, FOR CEMENTED USE ONLY, QTY: (1), STERILE R. Recall # Z-0932-2010;

10) JOURNEY " UNI TIBIAL BASEPLATE, RIGHT MEDIAL/LEFT LATERAL, A/P 52 MM, M/L 30 MM, REF 71422235, FOR CEMENTED USE ONLY, QTY: (1), STERILE R. Recall # Z-0933-2010;

11) JOURNEY " UNI TIBIAL BASEPLATE, RIGHT MEDIAL/LEFT LATERAL, A/P 55 MM, M/L 32 MM, REF 71422236, FOR CEMENTED USE ONLY, QTY: (1), STERILE R. Recall # Z-0934-2010;

12) JOURNEY " UNI TIBIAL INSERT LEFT MEDIAL/RIGHT LATERAL, A/P 38 MM, M/L 24 MM, REF 71422241, QTY: (1), STERILE EO. Recall # Z-0935-2010;

13) JOURNEY " UNI TIBIAL INSERT LEFT MEDIAL/RIGHT LATERAL, A/P 38 MM, M/L 24 MM, REF 71422243, QTY: (1), STERILE EO. Recall # Z-0936-2010;

14) JOURNEY " UNI TIBIAL INSERT LEFT MEDIAL/RIGHT LATERAL, A/P 38 MM, M/L 24 MM, REF 71422244, QTY: (1), STERILE EO. Recall # Z-0937-2010;

15) JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/LEFT LATERAL, A/P 38 MM, M/L 24 MM, REF 71422245, QTY: (1), STERILE EO. Recall # Z-0938-2010;

16) JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/LEFT LATERAL, A/P 38 MM, M/L 24 MM, REF 71422246, QTY: (1), STERILE EO. Recall # Z-0939-2010;

17) JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/LEFT LATERAL, A/P 38 MM, M/L 24 MM, REF 71422247, QTY: (1), STERILE EO. Recall # Z-0940-2010;

18) JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/LEFT LATERAL, A/P 38 MM, M/L 24 MM, REF 71422248, QTY: (1), STERILE EO. Recall # Z-0941-2010;

19) JOURNEY " UNI TIBIAL INSERT LEFT MEDIAL/ RIGHT LATERAL, A/P 46 MM, M/L 27 MM, REF 71422251, QTY: (1), STERILE EO. Recall # Z-0942-2010;

20) JOURNEY " UNI TIBIAL INSERT LEFT MEDIAL/ RIGHT LATERAL, A/P 46 MM, M/L 27 MM, REF 71422252, QTY: (1), STERILE EO. Recall # Z-0943-2010;

21) JOURNEY " UNI TIBIAL INSERT LEFT MEDIAL/ RIGHT LATERAL, A/P 46 MM, M/L 27 MM, REF 71422253, QTY: (1), STERILE EO. Recall # Z-0944-2010;

22) JOURNEY " UNI TIBIAL INSERT LEFT MEDIAL/ RIGHT LATERAL, A/P 46 MM, M/L 27 MM, REF 71422254, QTY: (1), STERILE EO. Recall # Z-0945-2010;

23) JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/ LEFT LATERAL, A/P 46 MM, M/L 27 MM, REF 71422255, QTY: (1), STERILE EO. Recall # Z-0946-2010;

24) JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/ LEFT LATERAL, A/P 46 MM, M/L 27 MM, REF 71422256, QTY: (1), STERILE EO. Recall # Z-0947-2010;

25) JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/ LEFT LATERAL, A/P 46 MM, M/L 27 MM, REF 71422257, QTY: (1), STERILE EO. Recall # Z-0948-2010;

26) JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/ LEFT LATERAL, A/P 46 MM, M/L 27 MM, REF 71422258, QTY: (1), STERILE EO. Recall # Z-0949-2010;

27) JOURNEY " UNI TIBIAL INSERT LEFT MEDIAL/ RIGHT LATERAL, A/P 52 MM, M/L 30 MM, REF 71422261, QTY: (1), STERILE EO. Recall # Z-0950-2010;

28) JOURNEY " UNI TIBIAL INSERT LEFT MEDIAL/ RIGHT LATERAL, A/P 52 MM, M/L 30 MM, REF 71422262, QTY: (1), STERILE EO. Recall # Z-0951-2010;

29) JOURNEY " UNI TIBIAL INSERT LEFT MEDIAL/ RIGHT LATERAL, A/P 52 MM, M/L 30 MM, REF 71422263, QTY: (1), STERILE EO. Recall # Z-0952-2010;

30) JOURNEY " UNI TIBIAL INSERT LEFT MEDIAL/ RIGHT LATERAL, A/P 52 MM, M/L 30 MM, REF 71422264, QTY: (1), STERILE EO. Recall # Z-0953-2010;

31) JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/ LEFT LATERAL, A/P 52 MM, M/L 30 MM, REF 71422265, QTY: (1), STERILE EO. Recall # Z-0954-2010;

32) JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/ LEFT LATERAL, A/P 52 MM, M/L 30 MM, REF 71422266, QTY: (1), STERILE EO. Recall # Z-0955-2010;

33) JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/ LEFT LATERAL, A/P 52 MM, M/L 30 MM, REF 71422267, QTY: (1), STERILE EO. Recall # Z-0956-2010;

34) JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/ LEFT LATERAL, A/P 52 MM, M/L 30 MM, REF 71422268, QTY: (1), STERILE EO. Recall # Z-0957-2010;

35) JOURNEY " UNI TIBIAL INSERT LEFT MEDIAL/ RIGHT LATERAL, A/P 46 MM, M/L 27 MM, REF 71933296, QTY: (1), STERILE EO. Recall # Z-0958-2010;

36) JOURNEY " UNI TIBIAL INSERT LEFT MEDIAL/ RIGHT LATERAL, A/P 46 MM, M/L 27 MM, REF 71933297, QTY: (1), STERILE EO. Recall # Z-0959-2010;

37) JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/ LEFT LATERAL, A/P 46 MM, M/L 27 MM, REF 71933298, QTY: (1), STERILE EO. Recall # Z-0960-2010;

38) JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/ LEFT LATERAL, A/P 46 MM, M/L 27 MM, REF 71933299, QTY: (1), STERILE EO. Recall # Z-0961-2010;

39) JOURNEY " UNI TIBIAL INSERT LEFT MEDIAL/ RIGHT LATERAL, A/P 52 MM, M/L 30 MM, REF 71933300, QTY: (1), STERILE EO. Recall # Z-0962-2010;

40) JOURNEY " UNI TIBIAL INSERT LEFT MEDIAL/ RIGHT LATERAL, A/P 52 MM, M/L 30 MM, REF 71933301, QTY: (1), STERILE EO. Recall # Z-0963-2010;

41) JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/ LEFT LATERAL, A/P 52 MM, M/L 30 MM, REF 71933302, QTY: (1), STERILE EO. Recall # Z-0964-2010;

42) JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/ LEFT LATERAL, A/P 52 MM, M/L 30 MM, REF 71933303, QTY: (1), STERILE EO. Recall # Z-0965-2010;

43) JOURNEY " UNI TIBIAL BASEPLATE RIGHT MEDIAL/ LEFT LATERAL, A/P 38 MM, M/L 24 MM, REF 71422231, FOR CEMENTED USE ONLY, QTY: (1), STERILE. Recall # Z-0966-2010;

44) JOURNEY " UNI TIBIAL INSERT LEFT MEDIAL/ LEFT LATERAL, A/P 38 MM, M/L 24 MM, REF 71422242, Qty: (1), Sterile EO. Recall # Z-0967-2010

CODE
All lot numbers

RECALLING FIRM/MANUFACTURER
Smith & Nephew, Inc., Memphis, TN, by letter on December 23, 2009 and by e-mail and telephone on January 23, 2010. Firm initiated recall is ongoing.

REASON
The firm has received complaints of the base plates breaking in situ. If a breakage occurs, the broken base plate must be revised and/or changed. If left unrevised a broken base could lead to instability and premature wear of the construct.

VOLUME OF PRODUCT IN COMMERCE
38,750 units

DISTRIBUTION
Nationwide, Argentina, Switzerland, Australia, Canada, Belgium, Italy, Spain, Thailand, Austria; PROC, Finland, Germany, Malaysia, Portugal, Netherlands, Singapore, and England

Smith & Nephew
Medical & Radiation Emitting Device Recalls

FDA logo (this web site is not affiliated with the FDA)

Class 2 Recall

Journey Uni Tibial Baseplate, Right Medial / Left Lateral

Date Posted	March 03, 2010
Recall Number	Z-0930-2010
Product	Journey Uni Tibial Baseplate, Right Medial / Left Lateral, A/P 42 MM, M/L 25 MM, REF 71422232, for cemented use only, quantity: 1, sterile R, SMITH & NEPHEW, INC. MEMPHIS, TN 38116
Code Information	All Lot Numbers
Recalling Firm/ Manufacturer	Smith & Nephew Inc 1450 E. Brooks Rd Memphis, Tennessee 38116
For Additional Information Contact	David Archer 901-399-5427
Reason for Recall	The firm has received complaints of the base plates breaking in situ. If a breakage occurs, the broken baseplate must be revised and/or changed. If left unrevised a broken base could lead to instability and premature wear of the construct.
Action	All affected Smith & Nephew Sales Representatives were notified of problem and the recall overnight mail on 12/23/2009. All affected Smith & Nephew International Distributors were notified via e-mail and telephone on 01/23/2009. They were instructed to immediately quarantine the product for return. For questions, please contact the firm, Leah Easley at 901-399-6137.
Quantity in Commerce	628 units
Distribution	US and Argentina, Switzerland, Australia, Canada, Belgium, Italy, Spain, Thailand, Austria; PROC, Finland, Germany, Malaysia, Portugal, Netherlands, Singapore, and England

View Official FDA Notice

Information about the medical device recall process

The recall of the Smith and Nephew knee replacement systems, Oxinium Genesis II and Oxinium Profix, was a "voluntary recall." This does not necessarily mean the U.S. Food and Drug Administration (FDA) would not have forced a recall if the manufacturer had not acted first.

According the FDA "Medical Device Recalls" information:

"Recalls may be conducted on a firm's own initiative or by FDA request. If the company does not comply with FDA's recall request, the FDA can seek a court order to seize the product, require the manufacturer to cease distribution and/or require the manufacturer to notify all persons who use the product.

"Most recalls are carried out voluntarily by the manufacturer or distributor of the product. However, FDA can request a recall if the product is defective, could be a risk to health, or is in violation of FDA regulations, and the firm does not recall the product on their own. The cooperation between FDA and its regulated industries has proven to be the quickest and most reliable method to remove potentially dangerous products from the market."