Recall Z-0314-2020— Zimmer Biomet, Inc.
Class II · Terminated
Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2019-10-10, terminated 2020-05-19. It names one FDA 510(k) clearance: K150121. Product: Periarticulare Plates - Elbow, Humeral and Ulna Plates, Item Nos. 00234800504 00234800506 00234800508 00234800510 00234800512 00234800514 00234800604 00234800606 00234800608 00234800610 00234800612 00234800614 00234800712 00234800714 00234800716 00234800902 00234800904 00234800906 00234800908 00234800910 00234800912 00234800914 00234801002 00234801004 00234801006 00234801008 00234801010 00234801012. Reason: Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration)..
- Recalling firm
- Zimmer Biomet, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-10-10
- Terminated
- 2020-05-19
- Firm location
- Warsaw, IN, United States
510(k) clearances named in this recall
1 on FDA's recordK-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
Periarticulare Plates - Elbow, Humeral and Ulna Plates, Item Nos. 00234800504 00234800506 00234800508 00234800510 00234800512 00234800514 00234800604 00234800606 00234800608 00234800610 00234800612 00234800614 00234800712 00234800714 00234800716 00234800902 00234800904 00234800906 00234800908 00234800910 00234800912 00234800914 00234801002 00234801004 00234801006 00234801008 00234801010 00234801012
Reason for recall
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Data sourced from openFDA. This site is unofficial and independent of the FDA.