Z-1511-2018Class II

Flex Arm

Name: Z-1511-2018 Flex Arm
Creator: Synthes, Inc.
Published: 2018-03-05
License: https://open.fda.gov/license/

Synthes GmbH / initiated 2018-03-05 / Terminated / root cause: design

FDA source

Synthes, Inc. began a recall of Flex Arm Product Usage: The Synthes Flex Arm is a component of the Synthes Minimally Invasive Support System, which provides secure table mounting for... on 2018-03-05. FDA classified it as Class II and gives the reason as "Quick connect feature of instruments may be unable to connect to the male features of Flex Arm Adaptors, Insight Retractors, or other mating parts". 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-1511-2018
Classification: Class II
Status: Terminated
Initiated: 2018-03-05
Posted: 2018-04-24
Terminated: 2019-10-16
Recalling firm: Synthes GmbH
Product: Flex Arm Product Usage: The Synthes Flex Arm is a component of the Synthes Minimally Invasive Support System, which provides secure table mounting for minimally invasive spine surgery. The Flex Arm is designed to hold Synthes Minimally Invasive Retractors, which are connected to the Flex Arm by adapters.
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: Quick connect feature of instruments may be unable to connect to the male features of Flex Arm Adaptors, Insight Retractors, or other mating parts.
Root cause tag: design
FDA root cause: Device Design
Action: The firm sent an Urgent Product Recall letter dated March 21, 2018, to affected customers. The letter identified the affected product, problem and actions to be taken. For questions call 1-610-719-5450 or contact your DePuy Synthes Sales Consultant.
Quantity in commerce: 84
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Switzerland and Japan
Product codes and lots: Lot numbers 9833185, 9866629, 9888308, 9914323, 9940637, 9982802, H044106, H072780, H144265, H212060, H260544, H260547, H305886, H347867, H430221, H430230

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1511-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1511-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-02	2018-04-24

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)