FDA Medical Device Recalls (openFDA)
Zimmer Manufacturing B.V.: Herbert Cannulated Bone Screw System, Bone Screw, 6.5 mm Dia., 45 mm Length 47115504507 Herbert Cannulated Bone Screw System, Bone Screw, 6.5 mm Dia., 75 mm Length 47115507507 Herbert Cannulated Bone Screw System, Bone Screw, 6.5 mm Dia., 90 mm Length 47115509007
- Recall number
- Z-1680-2016
- Recalling firm
- Zimmer Manufacturing B.V.
- Product
- Herbert Cannulated Bone Screw System, Bone Screw, 6.5 mm Dia., 45 mm Length 47115504507 Herbert Cannulated Bone Screw System, Bone Screw, 6.5 mm Dia., 75 mm Length 47115507507 Herbert Cannulated Bone Screw System, Bone Screw, 6.5 mm Dia., 90 mm Length 47115509007
- Status
- Terminated
- Initiated
- 2016-05-04
- Posted
- 2016-05-16
- Terminated
- 2017-07-05
- Reason
- A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.
- Root cause
- Packaging change control
- Action
- All distributors will be notified via electronic mail. Distributors with affected lots will also be notified via courier. Hospitals risk managers and surgeons will be notified via recall notification letter, dated May 4, 2016.
- Quantity
- 90
- Distribution
- Worldwide distribution. US nationwide, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador, Australia, India, Hong Kong, Chile, Germany, Italy, France, Spain, UK, Sweden, Canada.
- Lot, serial or model codes
- LOTS: 63303808 63292589 63292588
- 510(k) numbers
- ["K143165"]
- PMA numbers
- not on file
- Product code
- HWC
- Firm FEI
- 1000132037
- Firm city
- Mercedita
- Firm state
- not on file
- Firm country
- PR
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