||December 11, 2013
||Terminated on July 15, 2015
|Recall Event ID
Screw, fixation, bone -
||Stryker Orthopaedics Cancellous Bone Screw
Howmedica Osteonics Corp.
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.
||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
Stryker Howmedica Osteonics Corp.
325 Corporate Dr
|For Additional Information Contact
||Ms. Christie Samsa
|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.
||Stryker sent notification letters/accountability forms via Fed Ex on October 1, 2013, with return receipt. to branches/agencies and hospital risk management, chief of orthopedics and surgeons.
Domestic branch locations were notified by e-mail on 9/16/2013.
The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to fax the Product Recall Acknowledgement Form to 855-251-3635, return the affected product to the attention of Regulatory Compliance, Stryker Orthopaedics, 325 Corporate Drive, Mahwah, New Jersey, 07430. Customers were instructed to attach the fluorescent organge PRODUCT REMEDIATION sticker to their return, indicating the Produc Remediation # RA 2013-145. Mark the outer box with the words "Product Recall."
Customers with questions were instructed to call 201-972-2100.
For questions regarding this recall call 201-831-5000.
|Quantity in Commerce
||Catalog Number 2030-6525-1- 4 units; Catalog No: 2029-5540-1-7 units
|Total Product Life Cycle
TPLC Device Report
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K)s with Product Code = HWC and Original Applicant = OSTEONICS CORP.