OrthoPediatrics ACL Reconstruction System recallZ-2538-2020 · OrthoPediatrics Corp · initiated Jun 5, 2020
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from OrthoPediatrics Corp or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Under Investigation by firm
What the company is doing
OrthoPediatrics Corporation issued Urgent Medical Device Correction notices dated June 5, 2020 to customers via email. Customers are advised to return affected product to OrthoPediatrics Corporation. Replacement product will be provided. Please contact customer service to arrange return of the affected product. No additional corrective actions need to be taken for product already implanted. Please complete and return the attached response form confirming your understanding of these instructions. Any questions regarding this recall can be directed to Kriss Anderson, VP of Quality Systems and Regulatory Affairs, at OrthoPediatrics at [email protected] or 574-267-0897.
Recall details
- Recall number
- Z-2538-2020
- Status
- Terminated
- Initiated by the company
- Jun 5, 2020
- Recalling firm
- OrthoPediatrics Corp
- Quantity
- 9 units
- Product code
- MBI
- FDA submissions
- K130217
- Distribution
- US Nationwide distribution.
Product description
OrthoPediatrics ACL Reconstruction System ShieldLoc 6mm implant component model number 10-1008-4060 - Product Usage: is intended for fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) Reconstruction.
Code information (models, lots, serial numbers)
UDI: (01)00841132122198(17)240722(10)214320319A Lot# 214320319A
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- OrthoPediatrics ACL Reconstruction System 10-1008-4060Orthopediatrics Corp. · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE1 recall0 reports
Product lines
Other devices under the same FDA submission
1 device cleared under K130217 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- OrthoPediatrics ACL Reconstruction System 10-1008-4070Orthopediatrics Corp. · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 85837).
- Z-2539-2020 · TerminatedOrthoPediatrics ACL Reconstruction System ShieldLoc 7mm implant component model number 10-1008-4070 - Product Usage: is intended for fixation of tendons and ligaments during orthop…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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