OrthoPediatrics PediLoc Locking Plate System, 4.5mm Contour Locking Compression Femur 8 Hole Plate Right. Used for pediatric patients as indicated for pelvic, small and long bone fractures.
FDA Recall Z-2057-2012 · Posted 2012-07-20
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Recalling FirmOrthoPediatrics Corp
Recall StatusTerminated
Product CodeHRS
Date Initiated2012-06-14
Date Terminated2013-04-30
Product Quantity15 devices
Reason for Recall
The device is a Left 8 hole plate but is incorrectly labeled and etched as a Right device.
Firm Action
On 15-June-2012, a follow-up, URGENT Recall of MIS-BRANDED PediLoc Locking Plate e-mail was sent to all Distributors and direct representatives to provide them with a written notification of the voluntary recall. The e-mail identified the affected product and the reason for the recall. It also instructed them to quarantine all identified devices from the affected lot number immediately. A certified Voluntary Recall notice was also sent as a follow up along with a return prepaid pouch for the return of the recalled device(s) and Mandatory Reply Form.
Root Cause
Error in labeling
Distribution Pattern
Worldwide Distribution -- USA, including states of IN, GA, MI, FL, MO, OH, and SC and country of Australia.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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