FDA Medical Device Recalls (openFDA)
Orthopediatrics Corp: Orthopediatrics IM Femoral Nail - 8mm x 30 cm, Rt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-034. The system is used for pediatric and small stature adult patients to stabilize fractures of the femoral shaft, subtrochanteric fractures, ipsilateral neck/shaft fractures, prophylactic nailing of impending pathologic fractures, nonunions and malunions, fixation of femurs that have been surgically prepared for correction of deformity.
- Recall number
- Z-0348-2010
- Recalling firm
- Orthopediatrics Corp
- Product
- Orthopediatrics IM Femoral Nail - 8mm x 30 cm, Rt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-034. The system is used for pediatric and small stature adult patients to stabilize fractures of the femoral shaft, subtrochanteric fractures, ipsilateral neck/shaft fractures, prophylactic nailing of impending pathologic fractures, nonunions and malunions, fixation of femurs that have been surgically prepared for correction of deformity.
- Status
- Terminated
- Initiated
- 2009-07-21
- Posted
- 2010-05-12
- Terminated
- 2010-10-25
- Reason
- The potential exists for the nails to fracture during insertion of the nail.
- Root cause
- Device Design
- Action
- Distributor consignees were notified by email dated July 28, 2009 and requested to return the recalled products and instrument sets. If there are questions regarding this issue, please contact Gary Barnett at 574-268-6379.
- Quantity
- 23 of all products
- Distribution
- Nationwide.
- Lot, serial or model codes
- Lots 105477 and 105478.
- 510(k) numbers
- ["K083726"]
- PMA numbers
- not on file
- Product code
- HSB
- 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