OrthoPediatrics ACL Reconstruction System ShieldLoc 7mm implant… — Class II medical device recall Z-2539-2020
Terminated recall by OrthoPediatrics Corp, reported 2020-07-15, distributed nationwide. ShieldLoc implant component of the ACL Reconstruction Systemlots may be labeled with the incorrect size. Produ
| Recall number | Z-2539-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | OrthoPediatrics Corp, Warsaw, IN, United States |
| Recall initiated | 2020-06-05 |
| Classified | 2020-07-08 |
| Reported by FDA | 2020-07-15 |
| Terminated | 2021-05-25 |
| Distributed | Nationwide (US) |
| Quantity | 11 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00841132122211 |
| Lot numbers | 214320319A02 |
| Model numbers | 10-1008-4070 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2539-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.