Z-0309-2011

3.5mm LCP Periarticular Proximal Humerus Plates Indicated for fractures and fracture dislocations...

Name: Z-0309-2011 3.5mm LCP Periarticular Proximal Humerus Plates Indicated for fractures and fracture dislocations...
Creator: Synthes USA (HQ), Inc.
Published: 2010-09-16
License: https://open.fda.gov/license/

Synthes GmbH / initiated 2010-09-16 / Terminated / root cause: manufacturing process

FDA source

Synthes USA (HQ), Inc. began a recall of 3.5mm LCP Periarticular Proximal Humerus Plates Indicated for fractures and fracture dislocations, osteotomies, and nonunions of the proximal humerus... on 2010-09-16. The reason FDA records is "screw can pass through plate hole". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0309-2011
Status: Terminated
Initiated: 2010-09-16
Posted: 2010-11-02
Terminated: 2015-04-16
Recalling firm: Synthes GmbH
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
Product code: HRS Plate, Fixation, Bone
Reason for recall: screw can pass through plate hole
Root cause tag: manufacturing process
FDA 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: [email protected]. 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 in commerce: 2849 units
Distribution: Worldwide distribution: USA and countries including: Bermuda, Korea, Italy, Japan, Georgia, Qatar and Turkey
Product codes and lots: 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.

Product code HRS

K082625Class IISynthes (USA) 3.5Mm Lcp Periarticular Proximal Humerus PlatesSynthes (Usa) / cleared 2008-12-17

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)