Claw and Claw II plates - used in foot surgery

Related information

Hazard alert - reduced strength and increased risk of failure

29 August 2014

Consumers and health professionals are advised that Wright Medical Australia, in consultation with the TGA, has issued a hazard alert regarding specific lots of its Claw and Claw II plates. Wright Medical Australia is also recalling unused stocks of the affected lots.

Claw and Claw II plates comprise plates and locking screws of various lengths, which are used in surgery to reposition and stabilise bones in the foot.

Claw plate

It has been identified that the stainless steel used in Claw and Claw II plates from the affected lots did not meet the manufacturing requirements, resulting in reduced strength and increased risk of warping under stress. If this occurs, the device could fail.

If this problem occurred during surgery, it would be corrected immediately. However, surgery time would be increased.

If an affected device has been implanted and did not fail during surgery, there is a remote possibility that it could fail before fusion of the bones occurs. If this happens, revision surgery will be required.

As of 25 August 2014, there have been no reports of patient injury or the need for revision surgery as a result of this issue.

Information for consumers

Wright Medical Australia has contacted surgeons to provide further information about this issue, including advice on how to treat affected patients.

If you have had a Claw or Claw II plate implanted in your foot, the likelihood of you experiencing any problems relating to this issue after your operation is very low. If the problem occurred during implantation, it would have been corrected immediately.

You are reminded to follow all post-operative instructions, including to avoid placing weight on the foot until advised by your surgeon that it has adequately healed.

If you have any questions or concerns about this issue, contact your surgeon.

Information for all health professionals

If you are treating a patient who has had fusion surgery on a foot and is concerned about this matter, reassure them that the likelihood of them experiencing any problems relating to this issue after their operation is very low. Advise them to follow all post-operative instructions.

If they continue to have questions or concerns, refer them to their surgeon.

Information for surgeons

Wright Medical Australia has contacted surgeons to provide further information about this issue, including advice on how to treat affected patients and details of the recall process.

Please check any unused Claw and Claw II plates you have in stock to see if they are from an affected lot. If they are, those plates should not be used. Instead, they should be quarantined before being returned to Wright Medical Australia.

The above issue may have been observed during surgery as reduced torque resistance or increased bending/compression.

If you are treating a patient who has had a Claw or Claw II plate implanted, reassure them that the likelihood of them experiencing any problems relating to this issue after their operation is very low.

Advise patients to follow the post-operative instructions, including to not bear weight on the foot before fusion occurs.

Prophylactic revision surgery is not recommended.

Affected lots

The affected lot and item numbers are:

Lot number Item number Description
1509955 40130130 Claw 3.5mm Plate 2 Hole 30mm
1487673 40240215 Claw II 2 Hole 15mm
1487674 40240215 Claw II 2 Hole 15mm
1487675 40240215 Claw II 2 Hole 15mm
1487676 40240215 Claw II 2 Hole 15mm
1490003 40240215 Claw II 2 Hole 15mm
1512150 40240215 Claw II 2 Hole 15mm
1512151 40240215 Claw II 2 Hole 15mm
1519497 40240215 Claw II 2 Hole 15mm
1519498 40240215 Claw II 2 Hole 15mm
1522019 40240215 Claw II 2 Hole 15mm
1522020 40240215 Claw II 2 Hole 15mm
1523747 40240215 Claw II 2 Hole 15mm
1523748 40240215 Claw II 2 Hole 15mm
1537072 40240215 Claw II 2 Hole 15mm
1537073 40240215 Claw II 2 Hole 15mm
1537162 40240215 Claw II 2 Hole 15mm
1539399 40240215 Claw II 2 Hole 15mm
1541615 40240215 Claw II 2 Hole 15mm
1541616 40240215 Claw II 2 Hole 15mm
1543148 40240215 Claw II 2 Hole 15mm
1543149 40240215 Claw II 2 Hole 15mm
1490004 40240220 Claw II 2 Hole 20mm
1490005 40240220 Claw II 2 Hole 20mm
1490199 40240220 Claw II 2 Hole 20mm
1490200 40240220 Claw II 2 Hole 20mm
1490201 40240220 Claw II 2 Hole 20mm
1490202 40240220 Claw II 2 Hole 20mm
1518483 40240220 Claw II 2 Hole 20mm
1519493 40240220 Claw II 2 Hole 20mm
1519494 40240220 Claw II 2 Hole 20mm
1519495 40240220 Claw II 2 Hole 20mm
1522021 40240220 Claw II 2 Hole 20mm
1522898 40240220 Claw II 2 Hole 20mm
1522899 40240220 Claw II 2 Hole 20mm
1522900 40240220 Claw II 2 Hole 20mm
1523735 40240220 Claw II 2 Hole 20mm
1523736 40240220 Claw II 2 Hole 20mm
1526519 40240220 Claw II 2 Hole 20mm
1526520 40240220 Claw II 2 Hole 20mm
1526521 40240220 Claw II 2 Hole 20mm
1538760 40240220 Claw II 2 Hole 20mm
1538761 40240220 Claw II 2 Hole 20mm
1539402 40240220 Claw II 2 Hole 20mm
1540715 40240220 Claw II 2 Hole 20mm
1540716 40240220 Claw II 2 Hole 20mm
1540717 40240220 Claw II 2 Hole 20mm
1542703 40240220 Claw II 2 Hole 20mm
1542704 40240220 Claw II 2 Hole 20mm
1542776 40240220 Claw II 2 Hole 20mm
1543491 40240220 Claw II 2 Hole 20mm
1543891 40240220 Claw II 2 Hole 20mm
1490367 40240225 Claw II 2 Hole 25mm
1490368 40240225 Claw II 2 Hole 25mm
1512152 40240225 Claw II 2 Hole 25mm
1521232 40240225 Claw II 2 Hole 25mm
1523734 40240225 Claw II 2 Hole 25mm
1523746 40240225 Claw II 2 Hole 25mm
1537160 40240225 Claw II 2 Hole 25mm
1537161 40240225 Claw II 2 Hole 25mm
1539401 40240225 Claw II 2 Hole 25mm
1541613 40240225 Claw II 2 Hole 25mm
1541614 40240225 Claw II 2 Hole 25mm
1542652 40240225 Claw II 2 Hole 25mm
1542774 40240225 Claw II 2 Hole 25mm
1542775 40240225 Claw II 2 Hole 25mm
1487670 40240230 Claw II 2 Hole 30mm
1487671 40240230 Claw II 2 Hole 30mm
1487672 40240230 Claw II 2 Hole 30mm
1512149 40240230 Claw II 2 Hole 30mm
1519496 40240230 Claw II 2 Hole 30mm
1523745 40240230 Claw II 2 Hole 30mm
1534796 40240230 Claw II 2 Hole 30mm
1537159 40240230 Claw II 2 Hole 30mm
1539400 40240230 Claw II 2 Hole 30mm
1540714 40240230 Claw II 2 Hole 30mm
1512153 40242020 Claw II Straight 20 x 20mm
1518480 40242020 Claw II Straight 20 x 20mm
1532497 40242020 Claw II Straight 20 x 20mm
1538075 40242020 Claw II Straight 20 x 20mm
1538076 40242020 Claw II Straight 20 x 20mm
1538332 40242020 Claw II Straight 20 x 20mm
1513144 40242025 Claw II Straight 20 x 25mm
1518479 40242025 Claw II Straight 20 x 25mm
1534798 40242025 Claw II Straight 20 x 25mm
1538331 40242025 Claw II Straight 20 x 25mm
1543489 40242025 Claw II Straight 20 x 25mm
1517327 40242525 Claw II Straight 25 x 25mm
1538333 40242525 Claw II Straight 25 x 25mm
1543490 40242525 Claw II Straight 25 x 25mm
1543488 40S20020 Claw Plate 20mm Interaxis

Reporting problems

Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).

The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.