Z-1822-2016 Class II Terminated
FDA device recall Z-1822-2016 was initiated by Biomet, Inc. on Apr 1, 2016 and is designated Class II. Reason for recall: Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the product becomes… The recall status is terminated (terminated May 23, 2017).
Recall Details
- Product Type
- Devices
- Report Date
- Jun 1, 2016
- Initiation Date
- Apr 1, 2016
- Termination Date
- May 23, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
Product Description
Various trauma and sports medicine instruments and implants. Pin, fixation, smooth.
Reason for Recall
Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the product becomes non-sterile and is used or implanted, it may lead to an infection.
Distribution Pattern
Worldwide Distribution - US (Nationwide) and globally to Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Ecaudor, The Netherlands, Japan, Korea, Malaysia, Mexico, Peru.
Code Information
Part #'s 24415 24416 27914 27922 328010 14-401440 14-450360 14-450365 14-450380 14-450390 35-361681 Lot #'s 679900 693860 729090 722660 668350 591000 591010 591020 652700 745110 752860 728860 652650 664410 664440 606280
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1822-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026