Various trauma and sports medicine instruments and implants. Plate, fixation, bone.
FDA device recall Z-1817-2016 · posted 2016-05-26 · Terminated
Recall details
- Recalling firm
- Biomet, Inc.
- 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.
- Action taken
- Zimmer Biomet sent an Urgent Medical Device Recall Notice dated April 1, 2016, to all affected customers. Customers were instructed to locate and return the affected product, and implanting surgeons were instructed to monitor patients. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Questions related to this notice should be directed to (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m.
- Root cause
- Equipment maintenance
- Status
- Terminated
- Product code
- HRS
- Distribution
- Worldwide Distribution - US (Nationwide) and globally to Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Ecaudor, The Netherlands, Japan, Korea, Malaysia, Mexico, Peru.
- Date initiated
- 2016-04-01
- Date posted
- 2016-05-26
- Date terminated
- 2017-05-23
- Location
- Warsaw, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TRAUMA INTERNAL FIXATION SYSTEMS (K111663) | DePuy Orthopaedics, Inc. | 2012-03-12 |
| PEANUT GROWTH CONTROL PLATING SYSTEM (K093880) | Ebi, L.P. | 2010-04-16 |