Z-1276-2012

Osteonics Shoulder Glenoid Spanner Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430. The Solar...

Name: Z-1276-2012 Osteonics Shoulder Glenoid Spanner Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430. The Solar...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2011-11-17
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2011-11-17 / Terminated / root cause: manufacturing process

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Osteonics Shoulder Glenoid Spanner Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430. The Solar Upper Extremity System Hemi and Total Shoulder... on 2011-11-17. The reason FDA records is "Two product complaints reported that the Glenoid Reamer Spanner (Lot F3W7017) would not properly connect to the Glenoid Spherical Reamer". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1276-2012
Status: Terminated
Initiated: 2011-11-17
Posted: 2012-03-22
Terminated: 2012-12-19
Recalling firm: Howmedica Osteonics Corp
Product: Osteonics Shoulder Glenoid Spanner Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430. The Solar Upper Extremity System Hemi and Total Shoulder Arthroplasty system is designed to address the most common arthritic disorders affecting the shoulder. The spherical reamer is used to prepare the glenoid fossa and provide a uniform surface for instrumentation and implant placement. The glenoid fossa is then sized using surface templates to confirm the appropriate coverage, size and curvature has been determined. To achieve this in surgery, the spherical reamer (5900-2050/-2051/-2052/-2053) must be attached to the Angled Glenoid Driver (5900-2040) by threading the reamer's male threads into the driver's female threads. The spherical reamers come in sizes 5, 7, 9 & 11, each with a captive drill head screw (5900-2054/-2055). The spanner features two kidney shaped male lobes that mate with two similar kidney shaped female slots in the screw's head and is used to tighten and loosen the spherical reamers with the angled driver. These instruments are part of the Solar Total Shoulder Instrument set and can be found in Surgical Protocol LSPUE-4 dated 10/04. Each set contains one spanner that universally fits all size reamers.
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: Two product complaints reported that the Glenoid Reamer Spanner (Lot F3W7017) would not properly connect to the Glenoid Spherical Reamer.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Stryker sent an "URGENT PRODUCT RECALL" letter dated December 21, 2011 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. A Product Recall Acknowledgment Form was attached for customers to complete and return via fax to 201-831-6069. Contact the firm at 201-972-2100 for questions regarding this notice.
Quantity in commerce: five units
Distribution: Worldwide Distribution-USA (nationwide) and the country of Canada.
Product codes and lots: Description: Glenoid Reamer Spanner Catalog Number: 5900-2056 Lot Code: F3W7017 510k Exempt

Product code LXH

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)