FDA Medical Device Recalls (openFDA)
OrthoPediatrics Corp: Orthex Large Bone Shoulder Bolt, model no. AS-17
- Recall number
- Z-0277-2023
- Recalling firm
- OrthoPediatrics Corp
- Product
- Orthex Large Bone Shoulder Bolt, model no. AS-17
- Status
- Open, Classified
- Initiated
- 2022-09-12
- Posted
- 2022-11-22
- Terminated
- not on file
- Reason
- 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.
- 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 jbatts@orthopediatrics.com or 574-367-5396.
- Quantity
- 1354 (594 US)
- Distribution
- Domestic distribution to Foreign distribution to
- Lot, serial or model codes
- UDI-DI: 00841132143155 Lots: 921052140-E 922000760-E 922023360-E 922023370-E 922038571-E 922038581-E 922038591-E
- 510(k) numbers
- ["K151881"]
- PMA numbers
- not on file
- Product code
- OSN
- Firm FEI
- 3006460162
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28