FDA Medical Device Recalls (openFDA)
Zimmer Dental Inc: Outer Package Label: Tapered Screw-Vent Implant System, 4.1mm X 10mm, 3.5mm, REF:TSVM4B10, Sterile:R, Rx Only; Inner Package Label: Implant, MTX, 3.7mm x 10mm,3.5mm, REF: TSVB10. Zimmer Dental Implants are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.
- Recall number
- Z-2963-2018
- Recalling firm
- Zimmer Dental Inc
- Product
- Outer Package Label: Tapered Screw-Vent Implant System, 4.1mm X 10mm, 3.5mm, REF:TSVM4B10, Sterile:R, Rx Only; Inner Package Label: Implant, MTX, 3.7mm x 10mm,3.5mm, REF: TSVB10. Zimmer Dental Implants are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.
- Status
- Terminated
- Initiated
- 2018-05-10
- Posted
- not on file
- Terminated
- 2020-08-19
- Reason
- Dental implants have incorrect item/lot numbers and size on the inner package labeling. Correct item/lot numbers and size are on the outer package labeling.
- Root cause
- Labeling mix-ups
- Action
- The firm, Zimmer Biomet, sent an "Medical Device Recall" notice dated 5/10/2018 via FedEx/UPS courier to its customers. OUS distributors received a "distributor" notice. The notice described the product, problem and actions to be taken. The Customers were instructed to immediately return affected product to Field Action, PM Regulatory Compliance, Zimmer Biomet, 4555 Riverside Dr., Palm Beach Gardens, FL 33410 US and asked to complete and return a Certificate of Acknowledgement. and send to CorporateQuality.PostMarket@zimmerbiomet.com. If you have further questions or concerns, please call the Recall Department at 561-776-6700 between 8:00 am and 5:00 pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a prompt to leave a voicemail. Alternatively, your questions may be emailed to CorporateQuality.PostMarket@zimmerbiomet.com.
- Quantity
- 299 units
- Distribution
- Worldwide Distribution: US (nationwide) in states of: AL, CA, CO, CT, FL, GA, ID, IL, MA, MD, MI, MN, MO, NH, NJ, NY, PA,TN, TX, UT, VA, and WA; and to countries of: Australia, Bulgaria, Canada, Croatia, France, Germany, Italy, Portugal, and Spain.
- Lot, serial or model codes
- Outer Package Label: LOT: 63781164, UDI: (01) 00889024019621 (10) 63781164 (17) 220930 (10) 63781164; Inner Package Label: LOT: 63773888, UDI: (01) 00889024019508 (17) 220930 (10)63773888.
- 510(k) numbers
- ["K111889"]
- PMA numbers
- not on file
- Product code
- DZE
- Firm FEI
- 1038806
- Firm city
- Carlsbad
- Firm state
- CA
- 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