FDA Medical Device Recalls (openFDA)
Zimmer Inc.: Zimmer HGP II Acetabular Components Bone Screw, self-tapping, 6.5 mm dia., 35 mm length, tivanium TI-6AL-4V alloy, sterile, Catalog no. 6624-65-35 (00662406535).
- Recall number
- Z-1346-06
- Recalling firm
- Zimmer Inc.
- Product
- Zimmer HGP II Acetabular Components Bone Screw, self-tapping, 6.5 mm dia., 35 mm length, tivanium TI-6AL-4V alloy, sterile, Catalog no. 6624-65-35 (00662406535).
- Status
- Terminated
- Initiated
- 2006-06-26
- Posted
- 2006-08-03
- Terminated
- 2007-12-05
- Reason
- Lack of assurance of sterility, as the sterile barrier packaging may have been compromised.
- Root cause
- Other
- Action
- Hospital accounts were notified via recall letter dated 6/26/06 and distributor accounts were notified via recall letter dated 6/28/06 to return the product. Recall was extended to additional lots via recall letter dated 7/26/06.
- Quantity
- 310 total for all catalog numbers
- Distribution
- Worldwide, including USA, Argentina, Brazil, Canada, China, England, France, Germany, Guatemala, Israel, Japan, Jordan, Lebanon, Poland, Saudi Arabia, Singapore, Spain, Taiwan, UAE.
- Lot, serial or model codes
- Lots 12662700, 12718800, 12718900, 12757600, 12808600, 13331900, 13776600, 13776700, 13935600, 14196100, 14238900, 15590000, 15590100, 15610700, 16419200, 16579200, 16718400, 16718500, 16718600, 43764000, 48387800, 49078400, 49539800, 51295600, 52044900, 57690600, 57690800, 58905500, 59114400, 59476000, 66527800, 66527900, 66816800, 68890400, 68890500, 68890600 and 69606300.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HWC
- 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