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Open, Classified

PILLAR SA Ti, STERILE, 37mm (W) x 28mm (D) x 18mm (H), 20-degrees, REF: 82-3713SP

FDA Recall Z-2555-2025 · Posted 2025-09-11

Recalling FirmOrthofix U.S. LLC
Recall StatusOpen, Classified
Product CodeMAX
Date Initiated2025-06-24
Product Quantity3

Reason for Recall

A 37 mm implant width intervertebral body fusion device has a labeling discrepancy with incorrect width of 33 mm stated on the outer label side flap and inner label side flap information box. The 37 mm width on the front labels is correct.

Firm Action

On 6/24/2025, recall notes were emailed to customers who were asked to do the following: 1) Examine your inventory and quarantine any affected product. 2) If implanted, healthcare Providers should determine whether it is necessary to inform the patient, based on clinical judgment and individual circumstances. 3) This notice should be shared with all relevant personnel within your organization and forwarded to any other organization or facility where potentially affected devices may have been transferred. 4) Complete and return the response form to the firm. Should you have any questions regarding this matter, please contact the firm at [email protected]

Root Cause

Labeling design

Distribution Pattern

US Nationwide distribution in the states of CO, CA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

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

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