FDA Device recall Z-2539-2020
OrthoPediatrics ACL Reconstruction System ShieldLoc 7mm implant component model number 10-1008-4070 - Product Usage: is intended for fixati…
- FDA Device
- Class II
- terminated
- Published 2020-07-15
On 2020-07-15 the FDA classified a Class II recall of OrthoPediatrics ACL Reconstruction System ShieldLoc 7mm implant component model number 10-1008-4070 - Product Usage: is intended for fixati… by Orthopediatrics, citing shieldLoc implant component of the ACL Reconstruction Systemlots may be labeled with the incorrect size. Product labeled as 10-1008-4070 was found to have 10-1008-4060 product in….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2539-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-06-05 |
| Published | 2020-07-15 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Orthopediatrics |
| Distribution | US |
Product
OrthoPediatrics ACL Reconstruction System ShieldLoc 7mm implant component model number 10-1008-4070 - Product Usage: is intended for fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) Reconstruction.
Reason
ShieldLoc implant component of the ACL Reconstruction Systemlots may be labeled with the incorrect size. Product labeled as 10-1008-4070 was found to have 10-1008-4060 product in the package. Product labeled as 10-1008-4060 was found to have 10-1008-4070 product in the package.
Identifiers
| code_info | UDI: (01)00841132122211(17)240722(10)214320319A02 Lot#: 214320319A02 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
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FDA Device · Class II · 2022-09-14 · Orthopediatrics - Orthopedics 6.0MM ROD, COCR, SINGLE HEX, 500MM LENGTH-The RESPONSE" 5.5/6.0 Spine System is intended for immobilization and stabilization o…
FDA Device · Class II · 2020-08-05 · Orthopediatrics - OrthoPediatrics ACL Reconstruction System ShieldLoc 6mm implant component model number 10-1008-4060 - Product Usage: is intended for fixati…
FDA Device · Class II · 2020-07-15 · Orthopediatrics - Model No. 01-1501-0032 (Child Nail Attachment Bolt)
FDA Device · Class II · 2019-11-06 · Orthopediatrics
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2539-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.