Z-0151-2009

Ray TFC Device with End Caps: Single Patient use; Sterile; Stryker Spine Ray Cage 7-2021 20 (catalog #) mm...

Name: Z-0151-2009 Ray TFC Device with End Caps: Single Patient use; Sterile; Stryker Spine Ray Cage 7-2021 20 (catalog #) mm...
Creator: Stryker Spine
Published: 2008-08-18
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2008-08-18 / Terminated / root cause: labeling and UDI

FDA source

Stryker Spine began a recall of Ray TFC Device with End Caps: Single Patient use; Sterile; Stryker Spine Ray Cage 7-2021 20 (catalog #) mm diameter x 21 mm long. Ray Cages are indicated for... on 2008-08-18. The reason FDA records is "The label on one side on the Ray TFC Device (Ray Cage) is incorrect. It reads 20 mm x 26 mm instead of 20 mm x 21 mm". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0151-2009
Status: Terminated
Initiated: 2008-08-18
Posted: 2008-10-20
Terminated: 2008-11-04
Recalling firm: Howmedica Osteonics Corp
Product: Ray TFC Device with End Caps: Single Patient use; Sterile; Stryker Spine Ray Cage 7-2021 20 (catalog #) mm diameter x 21 mm long. Ray Cages are indicated for use with autogenous bone graft in patients with Degenerative Disc Disease (DDD) at one or two levels for L2 to S1.
Product code: MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Reason for recall: The label on one side on the Ray TFC Device (Ray Cage) is incorrect. It reads 20 mm x 26 mm instead of 20 mm x 21 mm.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Urgent Product Recall notification letters were sent via Fed Express on August 18, 2008 to Stryker Branches and Hospital Risk Managers. The firm asked customers to examine their inventory and hospital locations to identify the product; reconcile all products on the Product Accountability Form and attached distribution sheet; and fax a copy of the Accountability Form and distribution sheet to Sarah Thompson within 5 days of receipt of the notice. All questions are to be directed to Susan Krasny at 201-760-8150.
Quantity in commerce: 69 units
Distribution: Nationwide Distribution
Product codes and lots: Lot code 07A259

Product code MAX

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)