Recall Z-2539-2020
OrthoPediatrics Corp · initiated June 5, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: UDI: (01)00841132122211(17)240722(10)214320319A02 Lot#: 214320319A02
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.
FDA-determined cause: Under Investigation by firm
Action taken
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 kanderson@orthopediatrics.com or 574-267-0897.
Details
- Recall number
- Z-2539-2020
- Initiated
- June 5, 2020
- Terminated
- May 25, 2021
- Product code
- MBI – Fastener, Fixation, Nondegradable, Soft Tissue
- Quantity
- 11 units
- Distribution
- US Nationwide distribution.
- Recalling firm
- OrthoPediatrics Corp, Warsaw, IN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2538-2020 Class II | OrthoPediatrics ACL Reconstruction System ShieldLoc 6mm implant component model number…ShieldLoc implant component of the ACL Reconstruction Systemlots may be labeled with the incorrect size.… | 06/05/2020Terminated |