FDA Medical Device Recalls (openFDA)
Zimmer, Inc.: Bigliani/Flatow The Complete Shoulder Solution, Humeral Stem Provisional 12mm x 170mm This reusable trial device is used in orthopaedic joint replacement and is specific to the replaced joint (e.g. hip, knee, shoulder, ankle, elbow). It can be made of metal or plastic.
- Recall number
- Z-1676-2013
- Recalling firm
- Zimmer, Inc.
- Product
- Bigliani/Flatow The Complete Shoulder Solution, Humeral Stem Provisional 12mm x 170mm This reusable trial device is used in orthopaedic joint replacement and is specific to the replaced joint (e.g. hip, knee, shoulder, ankle, elbow). It can be made of metal or plastic.
- Status
- Terminated
- Initiated
- 2013-06-11
- Posted
- 2013-07-10
- Terminated
- 2014-01-30
- Reason
- The firm is initiating a removal of one lot of the Bigliani/Flatow Humeral Provisional Stem (00-4301-012-17, lot 62283991) as the stems manufactured under the lot are 14mm x 170mm devices incorrectly etched and packaged as 12mm x 170mm devices.
- Root cause
- Packaging process control
- Action
- Zimmer sent an URGENT MEDICAL DEVICE RECALL notification dated June 11, 2013, to all consignees via email and courier describing the affected device and problem and the risks associated with using the affected device. The notifications provided instructions for returning the affected device to Zimmer Product Service Department, 1777 West Center Street, Warsaw, IN 46580. Any questions or concerns concerning the recall, please call the customer call center at 1-877-946-2761. Customers may report adverse events or quality problems experienced with the use of these products to Zimmer by email at zimmer.per@zimmer.com. For questions regarding this recall call 800-613-6131.
- Quantity
- 1
- Distribution
- Nationwide Distribution including IL and MO.
- Lot, serial or model codes
- Item 00-4301-012-17; lot 62283991
- 510(k) numbers
- ["K110791"]
- PMA numbers
- not on file
- Product code
- HSD
- 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