Stryker Howmedica Osteonics Corp.: 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.

Recall number

Z-1276-2012

Recalling firm

Stryker 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.

Status

Terminated

Initiated

2011-11-17

Posted

2012-03-22

Terminated

2012-12-19

Reason

Two product complaints reported that the Glenoid Reamer Spanner (Lot F3W7017) would not properly connect to the Glenoid Spherical Reamer.

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

five units

Distribution

Worldwide Distribution-USA (nationwide) and the country of Canada.

Lot, serial or model codes

Description: Glenoid Reamer Spanner Catalog Number: 5900-2056 Lot Code: F3W7017 510k Exempt

510(k) numbers

not on file

PMA numbers

not on file

Product code

LXH

Firm FEI

3003070421

Firm city

Mahwah

Firm state

NJ

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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