Z-1618-2012

Cutting Edge Acetabular Spherical Reamer 44 M, Stryker Howmedica Osteonics Howmedica Osteonics Corp. 325...

Name: Z-1618-2012 Cutting Edge Acetabular Spherical Reamer 44 M, Stryker Howmedica Osteonics Howmedica Osteonics Corp. 325...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2011-12-23
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2011-12-23 / Terminated / root cause: design

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Cutting Edge Acetabular Spherical Reamer 44 M, Stryker Howmedica Osteonics Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 USA. The CuttingEdge... on 2011-12-23. The reason FDA records is "A 46mm acetabular reamer was lasermarked as a 44m reamer and distributed to the field". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1618-2012
Status: Terminated
Initiated: 2011-12-23
Posted: 2012-05-17
Terminated: 2013-07-17
Recalling firm: Howmedica Osteonics Corp
Product: Cutting Edge Acetabular Spherical Reamer 44 M, Stryker Howmedica Osteonics Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 USA. The CuttingEdge acetabular reamers are used to ream the acetabulum and prepare the bone for the insertion of the shell during hip arthroplasty. Surgical procedures for shells used with CuttingEdge instruments indicate that reaming should begin with a Spherical Reamer that is 4mm smaller than the templated or gauged size of the planned shell. Per the procedures, reaming should increase in size by 1mm increments until final sizing is achieved. Surgical judgment is used to assess bone stock, bone quality, desired level of press fit, and proper amount of reaming.
Product code: HTO Reamer
Reason for recall: A 46mm acetabular reamer was lasermarked as a 44m reamer and distributed to the field.
Root cause tag: design
FDA root cause: Device Design
Action: Stryker sent an "URGENT PRODUCT RECALL" letter dated December 29, 2011 to all affected customers. Notification letters and Product Accountability Forms were sent to Stryker accounts via FedEx on January 3, 2012 with return receipt. Hospital Risk Management and Chief of Orthopaedics Notification letters and Product Recall Acknowledgement Forms were sent on January 10, 2012. Surgeon Notification letters and Product Recall Acknowledgement Forms were sent on January 10, 2012. Notification sent via e-mail toCanada.EMEA, LatinAmerica.Asia Pacific on December 23, 2011. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to return the affected product. A Product Recall Acknowledgment Form was attached to the letter for customers to complete and return. Contact the firm at 201-972-2100 for questions regarding this recall.
Quantity in commerce: 134 units
Distribution: Worldwide Distribution.
Product codes and lots: Catalog Number 2102-0444 Lot number V2010068 No 510 K number No expiration date

Product code HTO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)