FDA Medical Device Recalls (openFDA)
Zimmer Biomet, Inc.: A.L.P.S. MIS Calcaneus Locking Plate LG RT F.A.S.T. Guide inserts, Item Number: 816209003,UDI: 00887868044670989403
- Recall number
- Z-1306-2018
- Recalling firm
- Zimmer Biomet, Inc.
- Product
- A.L.P.S. MIS Calcaneus Locking Plate LG RT F.A.S.T. Guide inserts, Item Number: 816209003,UDI: 00887868044670989403
- Status
- Terminated
- Initiated
- 2017-10-25
- Posted
- not on file
- Terminated
- 2020-05-01
- Reason
- The drill guides were manufactured with the incorrect color anodization.
- Root cause
- Unknown/Undetermined by firm
- Action
- DISTRIBUTORS: Review this notification and ensure that affected team members are aware of the contents. 1. Review this notification and ensure affected team members are aware of the contents. 2. Immediately locate and quarantine affected product in your inventory. 3. Complete the Certification of Acknowledgement portion of Attachment 1 Inventory Return Certification Form. a. Return a digital copy to corporatequality.postmarket@zimmerbiomet.com within three (3) days. 4. Immediately return all affected product from your distributorship and affected hospitals within your territory along with a completed Attachment 1 Inventory Return Certification Form to Zimmer Biomet. a. Request a Return Authorization Number 5. Return the Additional Accounts form to CorporateQuality.PostMarket@zimmerbiomet.com RISK MANAGERS: 1. Review this notification and notify affected personnel of the contents. 2. Assist your Zimmer Biomet sales representative and quarantine all affected product. 3. Complete Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com.
- Quantity
- 22
- Distribution
- Distributed in the following US States: AZ, MO, MT, NJ, NY, OH, TX, and WA. Distributed in Chile and Netherlands.
- Lot, serial or model codes
- Package Lot: 989430; Lot Etched on Product: P0284
- 510(k) numbers
- ["K093474","K111663"]
- PMA numbers
- not on file
- Product code
- HRS
- Firm FEI
- 1825034
- 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