FDA Medical Device Recalls (openFDA)
Zimmer Biomet, Inc.: Bone Dowell Harvest Tubes
- Recall number
- Z-2059-2017
- Recalling firm
- Zimmer Biomet, Inc.
- Product
- Bone Dowell Harvest Tubes
- Status
- Terminated
- Initiated
- 2017-04-12
- Posted
- 2017-04-25
- Terminated
- 2017-11-03
- Reason
- mislabeled as 8mm tube but it is actually 9 mm in size. A 9mm subcomponent was erroneously substituted and etched as 8mm for the actual 8mm subcomponent part.
- Root cause
- Nonconforming Material/Component
- Action
- On 4/12/2017 URGENT MEDICAL DEVICE RECALL REMOVAL notifications were sent to the affected consignees via e-mail. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification.
- Quantity
- 49
- Distribution
- No US distribution. JAPAN NETHERLANDS SINGAPORE SWITZERLAND
- Lot, serial or model codes
- Part Number: 900738 Lot Number (LN): 889990
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LXH
- 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