510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0993-2018Class II

Juggerknot 2.9Mm 2 #2 Mb

Zimmer GmbH / initiated 2017-06-30 / Terminated / root cause: packaging

Zimmer Biomet, Inc. began a recall of JUGGERKNOT 2.9MM 2 #2 MB Product Usage: For use in hip arthroplasty on . FDA classified it as Class II and gives the reason as "For soft tissue fixation". As of , the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number
Z-0993-2018
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Zimmer GmbH
Product
JUGGERKNOT 2.9MM 2 #2 MB Product Usage: For use in hip arthroplasty
Product code
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Reason for recall
For soft tissue fixation
Root cause tag
packaging
FDA root cause
Packaging process control
Action
On June 2, 2017 an URGENT Medical Recall Letter was issued to customers regarding affected product(s). The letter requests customers to review the content and notify affected personnel of the recall. Assist the sales representative in quarantining affected product, which will be removed and returned to recalling firm and then replaced. All customers who may have received product from distributors are to be notified. Questions or concerns can be directed to 1-574-372-4847.
Quantity in commerce
50
Distribution
US in the state of Texas
Product codes and lots
Part number: 912050 Lot number: 221890

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-0993-2018
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-0992-2018Class IITerminatedVoluntary: Firm initiated
Z-0993-2018Class IITerminatedVoluntary: Firm initiated