Z-0024-2016Class II

Synthes Periarticular Insertion Handle for 4.5mm LCP Proximal Tibia Plates and Periarticular Aiming Arm for...

Name: Z-0024-2016 Synthes Periarticular Insertion Handle for 4.5mm LCP Proximal Tibia Plates and Periarticular Aiming Arm for...
Creator: Synthes (USA) Products LLC
Published: 2015-09-14
License: https://open.fda.gov/license/

Synthes (USA) Products LLC / initiated 2015-09-14 / Terminated / root cause: design

FDA source

Synthes (USA) Products LLC began a recall of Synthes Periarticular Insertion Handle for 4.5mm LCP Proximal Tibia Plates and Periarticular Aiming Arm for 4.5mm LCP Proximal Tibia Plates on 2015-09-14. FDA classified it as Class II and gives the reason as "Affected lots of Periarticular Aiming Arms and Insertion Handles (Part Numbers 03.120.001, 03.120.002, 03.120.004 and 03.120.005) for the 4.5 mm LCP Proximal Tibia Plates are not able to be secured to the subsequent...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0024-2016
Classification: Class II
Status: Terminated
Initiated: 2015-09-14
Posted: 2015-10-05
Terminated: 2016-07-15
Recalling firm: Synthes (USA) Products LLC
Product: Synthes Periarticular Insertion Handle for 4.5mm LCP Proximal Tibia Plates and Periarticular Aiming Arm for 4.5mm LCP Proximal Tibia Plates
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: Affected lots of Periarticular Aiming Arms and Insertion Handles (Part Numbers 03.120.001, 03.120.002, 03.120.004 and 03.120.005) for the 4.5 mm LCP Proximal Tibia Plates are not able to be secured to the subsequent versions of these devices as intended.
Root cause tag: design
FDA root cause: Device Design
Action: An urgent notice of medical device recall, dated September 14, 2015, was sent to end users and sales consultants to alert them to the issue and potential risks. Return of the completed response form and the affected devide was also requested.
Quantity in commerce: 172
Distribution: Nationally
Product codes and lots: Part Numbers: 03.120.005 03.120.004 03.120.002 03.120.001 with Lot Numbers: 1780076; 1797331; 1829300 1789754; 1802319; 1810706; 1810707; 5704446 1780074; 1829294; 1829296 1789751; 1802318; 1810704; 1810705; 1828749; 1879604

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0024-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0024-2016	Class II	Terminated	Voluntary: Firm initiated	2015-10-14	2015-10-05

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)