FDA Medical Device Recalls (openFDA)
Zimmer Inc.: Zimmer Trabecular Metal Shoulder Instrumentation Distal Pilot, 12 mm diameter, 170 mm length, non-sterile, catalog no. 4309-12-17 (00-4309-012-17).
- Recall number
- Z-1284-06
- Recalling firm
- Zimmer Inc.
- Product
- Zimmer Trabecular Metal Shoulder Instrumentation Distal Pilot, 12 mm diameter, 170 mm length, non-sterile, catalog no. 4309-12-17 (00-4309-012-17).
- Status
- Terminated
- Initiated
- 2006-06-16
- Posted
- 2006-07-27
- Terminated
- 2007-12-05
- Reason
- During provisional trialing, the instrument may become stuck in the humeral canal and require surgical removal.
- Root cause
- Other
- Action
- U.S. and international distributors were notified of the recall via letter dated 6/30/2006 to check customer inventories and to return recalled product to the firm. Trial implants were redesigned and reworked to eliminate the problem.
- Quantity
- 324 total
- Distribution
- Nationwide and worldwide including Australia, Canada, Germany, Italy and Spain.
- Lot, serial or model codes
- All lots.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HWT
- 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