FDA Device Recall Z-0014-2011: Stryker Howmedica Osteonics Corp.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0014-2011.

Recall Res Number

Z-0014-2011

Recalling Firm / Manufacturer

Stryker Howmedica Osteonics Corp.

FEI Number

3003070421

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2006-10-05

Date Posted

2010-10-06

Date Terminated

2010-10-07

Product Code

JWH

Event Number

50100

Product Quantity

7 units

Product Description 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.

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.

Action Details 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.

Distribution Pattern Nationwide Distribution -- Including Ohio.

Code Information / Serial Numbers Lot Code: LADLF

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Medical Device Recall: Z-0014-2011

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer