Z-0277-2023Class II

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

Name: Z-0277-2023 Orthex Large Bone Shoulder Bolt, model no. AS-17
Creator: OrthoPediatrics Corp
Published: 2022-09-12
License: https://open.fda.gov/license/

Orthopediatrics Corp / initiated 2022-09-12 / Open, Classified

FDA source

OrthoPediatrics Corp began a recall of Orthex Large Bone Shoulder Bolt, model no. AS-17 on 2022-09-12. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0277-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-09-12
Posted: 2022-11-22
Recalling firm: Orthopediatrics Corp
Product: Orthex Large Bone Shoulder Bolt, model no. AS-17
Product code: OSN Software For Diagnosis/Treatment
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.
FDA root cause: Under Investigation by 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.
Quantity in commerce: 1354 (594 US)
Distribution: Domestic distribution to Foreign distribution to
Product codes and lots: UDI-DI: 00841132143155 Lots: 921052140-E 922000760-E 922023360-E 922023370-E 922038571-E 922038581-E 922038591-E

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0277-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0277-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-22	2023-02-10

Product code OSN

K151881Class IIX-Fix Line AdditionsVilex IN Tennessee, Inc. / cleared 2016-03-24

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)