FDA Medical Device Recalls (openFDA)
Zimmer Biomet, Inc.: 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
- Recall number
- Z-0314-2020
- Recalling firm
- Zimmer Biomet, Inc.
- 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
- Status
- Terminated
- Initiated
- 2019-10-10
- Posted
- not on file
- Terminated
- 2020-05-19
- Reason
- Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
- Root cause
- Packaging change control
- Action
- The firm distributed Urgent Medical Device Correction letters to customers on October 10, 2019. The letter informed customers that the previous version of low density polyethylene (LDPE) bag could potentially adhere to the surface of metal devices. Please note, this is separate from the previous recall for highly polished implants packaged in the previous version of the LDPE bags. Customers were asked to take the following actions: 1. Review this notification and ensure that pertinent personnel are aware of the contents. 2. Ensure that backup devices for the affected products are available, as per standard orthopedic procedure planning, to reduce the likelihood of an extension of surgery time. 3. Examine devices thoroughly for adherent LDPE bag residue prior to use. Use a backup device if LDPE bag residue is detected. 4. Return any devices which display adherent LDPE bag residue to Zimmer Biomet, consistent with the standard instructions for use regarding the disposition of damaged components. 5. Complete the Certificate of Acknowledgement and return to the firm. 6. Retain a copy of the acknowledgement form with your field action records in the event of a compliance audit of your facility's documentation. If you have further questions or concerns regarding this recall, please call the firm's customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to CorporateQuality.PostMarket@zimmerbiomet.com.
- Quantity
- 5,459,583 total devices
- Distribution
- Distributed nationwide.
- Lot, serial or model codes
- All product manufactured prior to January 2014.
- 510(k) numbers
- ["K150121"]
- PMA numbers
- not on file
- Product code
- HRS
- Firm FEI
- 1000220733
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28