Medical Device Recall: Z-0024-2016

FDA Recalls dataset · Firm: Synthes (USA) Products LLC · Status: Terminated

Recall Action Class: N/A Date Initiated: 2015-09-14 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0024-2016.

Recall Res Number
Z-0024-2016
Recalling Firm / Manufacturer
FEI Number
3008812560
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2015-09-14
Date Posted
2015-10-05
Date Terminated
2016-07-15
Product Code
LXH
Event Number
72238
Product Quantity
172
Product Description Synthes Periarticular Insertion Handle for 4.5mm LCP Proximal Tibia Plates and Periarticular Aiming Arm for 4.5mm LCP Proximal Tibia Plates

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.

Action Details 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.

Distribution Pattern Nationally

Code Information / Serial Numbers 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

Related Establishments / Registrations

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This page represents an index of public-record FDA device recalls. It does not imply current safety or compliance status of the product. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Refer to official government sources for primary safety alerts.

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