Z-2538-2020Class II

OrthoPediatrics ACL Reconstruction System ShieldLoc 6mm implant component model number 10-1008-4060 -

Name: Z-2538-2020 OrthoPediatrics ACL Reconstruction System ShieldLoc 6mm implant component model number 10-1008-4060 -
Creator: OrthoPediatrics Corp
Published: 2020-06-05
License: https://open.fda.gov/license/

Orthopediatrics Corp / initiated 2020-06-05 / Terminated / root cause: labeling and UDI

FDA source

OrthoPediatrics Corp began a recall of OrthoPediatrics ACL Reconstruction System ShieldLoc 6mm implant component model number 10-1008-4060 - Product Usage: is intended for fixation of tendons and... on 2020-06-05. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2538-2020
Classification: Class II
Status: Terminated
Initiated: 2020-06-05
Posted: 2020-07-10
Terminated: 2021-05-25
Recalling firm: Orthopediatrics Corp
Product: 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.
Product code: MBI Fastener, Fixation, Nondegradable, Soft Tissue
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.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 9 units
Distribution: US Nationwide distribution.
Product codes and lots: UDI: (01)00841132122198(17)240722(10)214320319A Lot# 214320319A

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2538-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2538-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-15	2020-07-08
Z-2539-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-15	2020-07-08

Product code MBI

K130217Class IIOrthopediatrics Acl Reconstructive SystemOrthoPediatrics Corp. / cleared 2013-06-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)