Duracon Total Knee Distal Femoral Locking Screw for 5 mm Spacer; Product No. 6632-5-600. Made in Ireland; Howmedica Osteonics; 325 Corporate Drive, Mahwah, NJ 07430 Intended for primary or secondary reconstruction of the distal femur.
FDA Recall Z-0014-2011 · Posted 2010-10-06
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Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeJWH
Date Initiated2006-10-05
Date Terminated2010-10-07
Product Quantity7 units
Reason for Recall
Stryker Orthopaedics became aware that a box labeled as Duracon Total Knee Distal Femoral Locking Screws for 5 mm spacer, may actually contain a 10 mm screw.
Firm Action
Important Market Withdrawal Letters were sent via Federal Express October 5, 2006. The letters identified the affected product and the reason for recall. Customers were asked to examine their inventory to identify the product; and retrieve all affected product lots and return it their branch or agency warehouse for reconciliation. All product should be reconciled on the Product Accountability Form and the form should be faxed back. Customers are to contact a Customer Service Rep to re-order the product that is being returned. Questions can be directed to Rita Intorrella on 201-831-5825.
Root Cause
Labeling mix-ups
Distribution Pattern
Nationwide Distribution -- Including Ohio.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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