FDA Medical Device Recalls (openFDA)
Synthes USA (HQ), Inc.: 3.5mm LCP Periarticular Proximal Humerus Plates Indicated for fractures and fracture dislocations, osteotomies, and nonunions of the proximal humerus, particularly for patients with osteopenic bone
- Recall number
- Z-0309-2011
- Recalling firm
- Synthes USA (HQ), Inc.
- Product
- 3.5mm LCP Periarticular Proximal Humerus Plates Indicated for fractures and fracture dislocations, osteotomies, and nonunions of the proximal humerus, particularly for patients with osteopenic bone
- Status
- Terminated
- Initiated
- 2010-09-16
- Posted
- 2010-11-02
- Terminated
- 2015-04-16
- Reason
- screw can pass through plate hole
- Root cause
- Nonconforming Material/Component
- Action
- Synthes (USA) notified all Synthes Trauma Hospital accounts of record of this recall via an Urgent Medical Device Recall letter dated September 27, 2010. The notification included instructions for hospital accounts to immediately cease use of the product, examine inventory, remove the 3.5 mm LCP Periarticular Proximal Humerus Plates from their shelves and complete and return the attached Verification Section form via mail: Credit/Returns, Synthes, 1101 Synthes Avenue, Monument, CO 80132; fax: 610-215-9005 or Scan/email: FieldAction@synthes.com. If they have any of the identified devices, they were to call Synthes at 1-800-479-6329 to obtain Authorization number prior to completing Verification form. If you have any questions, please call 1-800-620-7025 x5403 or contact your Synthes Trauma Sales Consultant.
- Quantity
- 2849 units
- Distribution
- Worldwide distribution: USA and countries including: Bermuda, Korea, Italy, Japan, Georgia, Qatar and Turkey
- Lot, serial or model codes
- Catalog/model numbers: 02.123.020, 02.123.020S, 02.123..021, 02.123.021S, 02.123.022, 02.123.022S, 02.123.023, 02.123.023S, 02.123.024, 02.123.024S, 02.123.025, 02.123.025S, 02.123.026, 02.123.026S, 02.123.027, 02.123.027S, 02.123.028, 02.123.028S, 02.123.029, 02.123.029S, 02.123.030, 02.123.030S, 02.123.031, 02.123.031S, 02.123.032, 02.123.032S, 02.123.033, 02.123.033S, 02.123.040, 02.123.040S, 02.123.041, 02.123.041S, 02.123.042, 02.123.042S, 02.123.043, and 02.123.043S. Lot numbers range form 6371761 through 6443098.
- 510(k) numbers
- ["K082625"]
- PMA numbers
- not on file
- Product code
- HRS
- Firm FEI
- 3005180112
- Firm city
- West Chester
- Firm state
- PA
- 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