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Terminated

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.

FDA Recall Z-0151-2009 · Posted 2008-10-20

Recalling FirmStryker Spine
Recall StatusTerminated
Product CodeMAX
Date Initiated2008-08-18
Date Terminated2008-11-04
Product Quantity69 units

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.

Firm 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.

Root Cause

Labeling mix-ups

Distribution Pattern

Nationwide Distribution

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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