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Open, Classified

Orthex Large Bone Shoulder Bolt, model no. AS-17

FDA Recall Z-0277-2023 · Posted 2022-11-22

Recalling FirmOrthoPediatrics Corp
Recall StatusOpen, Classified
Product CodeOSN
Date Initiated2022-09-12
Product Quantity1354 (594 US)

Reason for Recall

Bolt breakage on the head or threaded portion, which may cause loss of strut continuity with frame. This may cause loss of deformity correction and/or disruption of bone regeneration.

Firm Action

On September 12, 2022, the firm notified distributors of the recall. Distributors were asked to notify and retrieve affected devices from end users. Affected product must be returned to OrthoPediatrics. Replacement product will be provided. Customers should contact customer service to arrange return of the affected product. Customers who have patients in frames should be made aware of the possibility of Bolt breakage and continue monitoring their patients. Any questions regarding this recall can be directed to Joel Batts, Senior VP of Clinical and Regulatory Affairs, at OrthoPediatrics at [email protected] or 574-367-5396.

Root Cause

Under Investigation by firm

Distribution Pattern

Domestic distribution to Foreign distribution to

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K151881X-Fix Line AdditionsVilex IN Tennessee, Inc. · 2016-03-24

Official Source

View FDA Recall →

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

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