FDA Enforcement Class II Terminated

OsteoBridge Intremedullary Knee Arthrodesis (IKA) nails

Recall: Z-0435-2021 · Reported November 18, 2020

Enforcement

Recall Number
Z-0435-2021
Event ID
86526
Classification
Class II
Status
Terminated
Product Type
Devices
Firm
Merete Medical GmbH
Voluntary / Mandated
Voluntary: Firm initiated
Initial Notification
E-Mail
Report Date
November 18, 2020
Initiation Date
September 18, 2020
Classification Date
November 6, 2020
Termination Date
May 13, 2021
Address
Alt-Lankwitz 102, Berlin, N/A, Germany

Description

OsteoBridge Intremedullary Knee Arthrodesis (IKA) nails

Reason

Product may be mislabeled.

Code Info

Lot and Use by Date MS1709826R 5/14/2025 MS1202321R 4/21/2025 MS1506568R 5/14/2025 MS1506568R 5/14/2025 MS1202321R1 7/16/2025 MS1709826R1 7/16/2025 MS1710592R 4/21/2025 MS1506583R 5/14/2025 MS1609272R 5/14/2025 MS1710592R1 7/16/2025 MS1405272R 7/16/2025 MS1609272R1 7/16/2025 MS1506583R1 7/16/2025 MS1609591R 4/21/2025 MS1609591R1 5/14/2025 MS1609591R1 5/14/2025 MS1709825R 7/16/2025 MS1609591R2 7/16/2025 MS1710265R 4/21/2025 MS1609590R 4/21/2025 MS1711008R1 5/14/2025 MS1609083R 7/16/2025 MS1711008R2 7/16/2025 MS1710265R1 7/16/2025 MS2014265 4/17/2025 MS2014265 4/17/2025 MS1710921R 4/27/2025 MS2014265 4/17/2025 MS1710921R1 7/16/2025 MS1912442R1 7/16/2025 MS1405010R 4/27/2025 MS1506989R 5/14/2025 MS1506989R 5/14/2025 MS1709827R 7/16/2025 MS1710266R 7/16/2025 MS1506989R 5/14/2025 MS1709827R 7/16/2025 MS1710266R 7/16/2025 MS1506989R 5/14/2025 MS1709827R 7/16/2025 MS1710266R 7/16/2025 MS1710746R 4/27/2025 MS1710525R 4/27/2025 MS1304331R 5/14/2025 MS1710525R1 7/16/2025 MS1609273R 7/16/2025 MS1812116R 4/27/2025 MS1609274R 4/27/2025 MS2014170 4/17/2025 MS2014170R 7/16/2025 MS1812116R1 7/16/2025 MS1202322R 4/28/2025 MS1609683R 5/14/2025 MS1609683R 5/14/2025 MS1609683R1 7/16/2025 MS1710744R 4/28/2025 MS1202323R 4/28/2025 MS1507012R 5/14/2025 MS1608472R 5/14/2025 MS1710744R1 7/16/2025 MS1202323R1 7/16/2025 MS1710745R 4/28/2025 MS1507606R 1/8/2025 MS1303859R1 5/14/2025 MS1304612R1 5/14/2025 MS1202641R1 5/14/2025 MS1710745R1 7/16/2025 MS1303859R2 7/16/2025 MS1202363R 4/28/2025 MS1710163R 4/28/2025 MS1506572R 5/14/2025 MS1506572R 5/14/2025 MS1710163R1 7/16/2025 MS1710666R 7/16/2025 MS1710665R 4/28/2025 MS1506584R 5/14/2025 MS1710665R1 5/14/2025 MS1710665R2 7/16/2025 MS1202364R 7/16/2025 MS1303916R 7/16/2025 MS1405901R 4/28/2025 MS1710693R 4/28/2025 MS1710693R1 5/14/2025 MS1710693R2 7/16/2025 MS1710164R 7/16/2025 MS1304195R 7/16/2025 MS1710693R2 7/16/2025 MS1710164R 7/16/2025 MS1304195R 7/16/2025 MS1710693R2 7/16/2025 MS1304195R 7/16/2025 MS1506546R1 5/14/2025 MS1608831R1 6/2/2025 MS1506546R1 5/14/2025 MS1506546R1 5/14/2025 MS1608831R1 6/2/2025 MS1202527R 7/20/2025 N020711R 4/29/2025 MS1608832R 4/29/2025 MS1405856R 6/2/2025 MS1608149R 6/2/2025 MS1608832R1 7/20/2025 MS1405856R1 7/20/2025 MS1406097R1 6/2/2025 MS1507541R 5/14/2025 MS1609333R 5/14/2025 MS1609333R 5/14/2025 MS1000716R 7/20/2025 MS1608462R 4/29/2025 MS1609058R 5/14/2025 MS1000717R 5/14/2025 MS1000717R 5/14/2025 MS1609058R1 7/21/2025 MS1202314R 4/29/2025 MS1709840R 4/29/2025 MS1406083R 5/14/2025 MS1608742R 6/2/2025 MS1406083R 5/14/2025 MS1405477R1 5/14/2025 MS1608833R 6/2/2025 MS1608833R 6/2/2025 MS1609057R 4/29/2025 MS1609057R1 5/13/2025 MS1608668R 6/2/2025 MS1000719R 5/13/2025 MS1000719R 5/13/2025 MS1711010R 6/2/2025 MS1711010R 6/2/2025 MS1711010R 6/2/2025 MS1506547R 5/13/2025 MS1609059R1 6/2/2025 MS1102136R1 6/2/2025 MS1609059R1 6/2/2025 MS1406153R 6/2/2025 MS1000651R 6/2/2025 MS1405338R 6/2/2025 MS1608322R 6/2/2025 MS1507841R 5/13/2025 MS1506545R 4/29/2025 MS1303917R 5/13/2025 MS1506545R1 5/13/2025 MS1506545R1 5/13/2025 MS1202346R1 7/21/2025 MS1203156R 7/21/2025 MS1303917R1 7/21/2025 MS1710740R 4/29/2025 MS1609334R1 5/13/2025 MS1609334R2 7/21/2025

Distribution

Product was distributed in US - CA, IL, MD, OH, and NJ

Quantity

306 units