Recall Z-2068-2017— Zimmer Biomet, Inc.

Name: FDA recall Z-2068-2017
Creator: U.S. Food and Drug Administration
Published: 2017-03-22

Class II · Terminated

Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2017-03-22, terminated 2017-10-03. It names one FDA 510(k) clearance: K083782. Product: Regenerex Patella RGX 3 PEG SER A PATELLA 28MM RGX 3 PEG SER A PATELLA 31MM RGX 3 PEG SER A PATELLA 34MM RGX 3 PEG SER A PATELLA 37MM Product Usage: The Regenerex Series A Patella can be used for any non-cemented resurfaced 3-peg patella application within the Vanguard Complete Knee System. 1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved. 2. Correction of varus, valgus, or posttraumatic deformity. 3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.. Reason: pegs shearing post-operatively.

Recalling firm: Zimmer Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-03-22
Terminated: 2017-10-03
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K083782 — REGENEREX PATELLA COMPONENTSBiomet Manufacturing Corp·cleared 2009-04-03

K-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

Regenerex Patella RGX 3 PEG SER A PATELLA 28MM RGX 3 PEG SER A PATELLA 31MM RGX 3 PEG SER A PATELLA 34MM RGX 3 PEG SER A PATELLA 37MM Product Usage: The Regenerex Series A Patella can be used for any non-cemented resurfaced 3-peg patella application within the Vanguard Complete Knee System. 1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved. 2. Correction of varus, valgus, or posttraumatic deformity. 3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.

Reason for recall

pegs shearing post-operatively

Data sourced from openFDA. This site is unofficial and independent of the FDA.