Recall Z-1678-2016— Zimmer Manufacturing B.V.
Class II · Terminated
Class II FDA medical device recall by Zimmer Manufacturing B.V., initiated 2016-05-04, terminated 2017-07-05. It names one FDA 510(k) clearance: K142281. Product: M/DN Intramedullary Fixation 4.2 mm Diameter Cortical Screw, 3.5 mm Hex Head, 45 mm Length 00225304542 M/DN Intramedullary Fixation 4.2 mm Diameter Cortical Screw, 3.5 mm Hex Head, 70 mm Length 00225307042. Reason: A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws..
- Recalling firm
- Zimmer Manufacturing B.V.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-05-04
- Terminated
- 2017-07-05
- Firm location
- Mercedita, PR, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
M/DN Intramedullary Fixation 4.2 mm Diameter Cortical Screw, 3.5 mm Hex Head, 45 mm Length 00225304542 M/DN Intramedullary Fixation 4.2 mm Diameter Cortical Screw, 3.5 mm Hex Head, 70 mm Length 00225307042
Reason for recall
A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.
Data sourced from openFDA. This site is unofficial and independent of the FDA.