FDA Medical Device Recalls (openFDA)
Zimmer Biomet, Inc.: Biomet Sports Medii cine Juggerknot Long Flex Drill Bit with Sleeve Nitinol intended to be used for soft tissue to bone fixation with indications for use in: Shoulder, Foot and Ankle, Knee, Hand and Wrist and Hip repair.Stainless Steel, Sterile Item Number: 110016992
- Recall number
- Z-3252-2018
- Recalling firm
- Zimmer Biomet, Inc.
- Product
- Biomet Sports Medii cine Juggerknot Long Flex Drill Bit with Sleeve Nitinol intended to be used for soft tissue to bone fixation with indications for use in: Shoulder, Foot and Ankle, Knee, Hand and Wrist and Hip repair.Stainless Steel, Sterile Item Number: 110016992
- Status
- Terminated
- Initiated
- 2018-08-03
- Posted
- not on file
- Terminated
- 2020-04-10
- Reason
- Expiration date incorrectly listed on the label
- Root cause
- Device Design
- Action
- Zimmer notified distributors on 8/3/18 distributors notified via email. Hospital risk managers, as well as distributors with product, notified via Fed'X. The letter identifies the issue and their responsibilities, locating and removing the product in their territory, as well as identifying hospitals who have fielded inventory. Product to be returned to Zimmer Biomet. Question customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday or to :CorporateQuality.PostMarket@zimmerbiomet.com
- Quantity
- 217 units
- Distribution
- AZ CO FL FL GA LA MA MA MO NY SC TX
- Lot, serial or model codes
- Lot Numbers: 053940, 545740, 067490, 664610, 165770, 676180, 165830, 688250, 415590, 860050
- 510(k) numbers
- ["K110145"]
- PMA numbers
- not on file
- Product code
- MBI
- 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