Stryker Howmedica Osteonics Corp.: Medical Device Recall in 2013 - (Recall #: Z-0483-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

Stryker Orthopaedics Cancellous Bone Screw Howmedica Osteonics Corp. Stryker France Both the 6.4 mm diameter, 25mm length, Cancellous Bone Screws (Cat no 2030-6525-1) and the 5.5mm diameter, 40 mm length Cancellous Bone Screws (Cat no 2029-5540-1) are cleared for use in Total Hip Arthroplasty (THA), when implanting Stryker's Hemispherical Cluster Hole Acetabular Shell Systems and Total Knee Arthroplasty (TKA) when implanting Stryker's Series 7000 Standard Tibial Tray systems. The use of bone screws, during both THA and TKA are intended as supplemental fixation.

Product Classification:

Class II

Date Initiated: October 1, 2013

Date Posted: December 18, 2013

Recall Number: Z-0483-2014

Event ID: 66908

Reason for Recall:

Stryker received a report from the field indicating that a 5.5 mm Cancellous Bone Screw 40 mm was identified in packaging associated with a 6.5 mm Cancellous Bone Screw 25 mm.

Status: Terminated

Product Quantity: Catalog Number 2030-6525-1- 4 units; Catalog No: 2029-5540-1-7 units

Code Information:

1) 6.5 mm Cancellous Bone Screw 25mm Catalog No: 2030-6525-1 Lot code MMLNLA 2) 5.5 Cancellous Bone Screw 40 mm Catalog No: 2029-5540-1 Lot Code MMLMJ1

Distribution Pattern:

Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated