Shortened Plug Driver; Low Volume Specialty Device; Qty:1; Rx Only; Non Sterile; Biomet Spine, Parsippany, NJ 07054 The
FDA device recall Z-0411-2014 · posted 2013-11-27 · Terminated
Recall details
- Recalling firm
- Ebi, Llc
- Reason for recall
- Biomet received a complaint on 5/20/2013 reporting that the tip of the instrument sheared off during a removal case.
- Action taken
- Biomet sent an Urgent Medical Device Recall Letters/Fax Back Response Form dated September 24, 2013, via Fed Ex. The customer is asked to examine their inventory and return the recalled product following the attached instructions. The Fax Back Response Form should be completed and returned to 973-887-1347 prior to the return of the product. Any questions please call (973) 299-9300 x 2162.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- HXX
- Quantity affected
- 2 units
- Distribution
- US Distribution to CA
- Date initiated
- 2013-09-24
- Date posted
- 2013-11-27
- Date terminated
- 2015-05-15
- Location
- Parsippany, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.