FDA Medical Device Recalls (openFDA)
Zimmer, Inc.: NEXGEN Complete Knee Solution Monoblock Tibial Drill with stop 10.7 mm. Used to prepare cylindrical holes in the native tibia.
- Recall number
- Z-1376-2013
- Recalling firm
- Zimmer, Inc.
- Product
- NEXGEN Complete Knee Solution Monoblock Tibial Drill with stop 10.7 mm. Used to prepare cylindrical holes in the native tibia.
- Status
- Terminated
- Initiated
- 2013-03-27
- Posted
- 2013-05-24
- Terminated
- 2017-01-26
- Reason
- Zimmer is initiating a lot specific recall of the Trabecular Metal" Tibia Stop Drill due to the potential of the outside diameter being oversized. As a result, there is a potential for the drill to not pass through the applicable drill guide.
- Root cause
- Process control
- Action
- Zimmer sent an "URGENT MEDICAL DEVICE RECALL LETTER" dated April 19, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers.
- Quantity
- 69 units
- Distribution
- Nationwide Distribution.
- Lot, serial or model codes
- Part No. 00-5887-052-00; lots 62181290 and 62183430
- 510(k) numbers
- ["K012866","K020295"]
- PMA numbers
- not on file
- Product code
- HTW
- 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