Skip to content

Stryker Orthopaedics Cancellous Bone Screw recallZ-2123-2009 · Stryker Howmedica Osteonics Corp. · initiated Jun 26, 2009

Terminated All recalls posted in September 2009

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Stryker Howmedica Osteonics Corp. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Raw material supplied by a third party used to manufacture various medical devices does not comply with metallurgical requirements outlines in ASTM standard for titanium surgical implants.

FDA root cause category: Nonconforming Material/Component

What the company is doing

Stryker Orthopaedics issued "Urgent Product Recall" letters via Federal Express priority overnight beginning June 26, 2009 to Branches, Hospital Risk Management and Chief of Orthopaedics and Surgeons. All users are requested to examine their inventory, retrieve all affected product and return for reconciliation to Stryker Orthopaedics. Users are also requested to complete the enclosed Product Accountability Form and fax with necessary information to the firm at 1-201-831-6069. For further information, contact Stryker Orthopaedics at 1-201-831-5970.

Recall details

Recall number
Z-2123-2009
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Jun 26, 2009
Posted by the FDA
Sep 14, 2009
Recalling firm
Stryker Howmedica Osteonics Corp.
Quantity
51,113 total - all sizes.
Product code
HWC
FDA submissions
K873251
Distribution
Worldwide Distribution

Product description

Stryker Orthopaedics Cancellous Bone Screw; Dia 6.5 mm; Lnth: 50 mm; Sterile: Made in the USA; Stryker Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430. The bone screws are optional fixtures that may be used during knee and hip replacement procedures.

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

Catalog number: 2030-6550-1; 6.5 CANCELLOUS BONE SCREW 50mm KKMMKE 22-Jun-2013 6.5 CANCELLOUS BONE SCREW 50mm NMXMKE 25-Jun-2013 6.5 CANCELLOUS BONE SCREW 50mm R89MKE 27-Jun-2013 6.5 CANCELLOUS BONE SCREW 50mm 8K6MLE 14-Jul-2013 6.5 CANCELLOUS BONE SCREW 50mm 8K4MLE 14-Jul-2013 6.5 CANCELLOUS BONE SCREW 50mm MAJMLE 25-Jul-2013 6.5 CANCELLOUS BONE SCREW 50mm MAHMLE 28-Jul-2013 6.5 CANCELLOUS BONE SCREW 50mm HVWMME 22-Aug-2013 6.5 CANCELLOUS BONE SCREW 50mm 3J4MNE 09-Sep-2013 6.5 CANCELLOUS BONE SCREW 50mm 5V4MNE 11-Sep-2013 6.5 CANCELLOUS BONE SCREW 50mm MER715 18-Nov-2013 6.5 CANCELLOUS BONE SCREW 50mm MER714 18-Nov-2013 6.5 CANCELLOUS BONE SCREW 50mm MERDR9 23-Nov-2013 6.5 CANCELLOUS BONE SCREW 50mm MERDRA 23-Nov-2013 6.5 CANCELLOUS BONE SCREW 50mm MERP11 05-Dec-2013 6.5 CANCELLOUS BONE SCREW 50mm MET0XY 07-Dec-2013 6.5 CANCELLOUS BONE SCREW 50mm MET27A 10-Dec-2013 6.5 CANCELLOUS BONE SCREW 50mm MET3M4 10-Dec-2013 6.5 CANCELLOUS BONE SCREW 50mm MET3M6 12-Dec-2013 6.5 CANCELLOUS BONE SCREW 50mm MET8YH 21-Dec-2013 6.5 CANCELLOUS BONE SCREW 50mm METE5N 21-Dec-2013 6.5 CANCELLOUS BONE SCREW 50mm METDV8 21-Dec-2013 6.5 CANCELLOUS BONE SCREW 50mm METNRN 04-Jan-2014 6.5 CANCELLOUS BONE SCREW 50mm METNRP 04-Jan-2014 6.5 CANCELLOUS BONE SCREW 50mm MHA0L5 11-Jan-2014 6.5 CANCELLOUS BONE SCREW 50mm MHA0MP 11-Jan-2014

Other devices under the same FDA submission

7 devices cleared under K873251 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 52713).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page