Z-1882-2016Class II

Torque Limiting Handle: PRECIMED, T-Handle Torque, Non Sterile. Handle: Customer Number/Model: MCL120014...

Name: Z-1882-2016 Torque Limiting Handle: PRECIMED, T-Handle Torque, Non Sterile. Handle: Customer Number/Model: MCL120014...
Creator: Greatbatch Medical
Published: 2016-04-26
License: https://open.fda.gov/license/

Greatbatch Medical / initiated 2016-04-26 / Terminated / root cause: design

FDA source

Greatbatch Medical began a recall of Torque Limiting Handle: PRECIMED, T-Handle Torque, Non Sterile. Handle: Customer Number/Model: MCL120014 T14000, TLT911-50-S20 TLT911-50-S20, TLT911-15-S01... on 2016-04-26. FDA classified it as Class II and gives the reason as "Greatbatch Medical has initiated a global Field Recall for Torque Limiting Devices. Greatbatch identified through laboratory testing that the required sterility assurance level (SAL) of 10-6 is not achieved on torque...". 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-1882-2016
Classification: Class II
Status: Terminated
Initiated: 2016-04-26
Posted: 2016-06-01
Terminated: 2018-06-07
Recalling firm: Greatbatch Medical
Product: Torque Limiting Handle: PRECIMED, T-Handle Torque, Non Sterile. Handle: Customer Number/Model: MCL120014 T14000, TLT911-50-S20 TLT911-50-S20, TLT911-15-S01 TLT911-15-S01, TLTS0007-20-S19 TLTS0007-20-S19, TLT911-35-S01 TLT911-35-S01.
Product code: HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
Reason for recall: Greatbatch Medical has initiated a global Field Recall for Torque Limiting Devices. Greatbatch identified through laboratory testing that the required sterility assurance level (SAL) of 10-6 is not achieved on torque limiting devices when subjected to steam sterilization cycles identified in the Instruction For Use (IFU) provided with the device.
Root cause tag: design
FDA root cause: Device Design
Action: Consignees were sent on 4/26/2016 a Greatbatch "Urgent Medical Device Recall" letter dated April 26, 2016. The letter described the product involved in the recall, the reason, and the risk to health. The letter advised consignees to identity and quarantine the product and to complete and return the Filed Recall Response Form. For questions contact your local Greatbatch Medical representative, at 1-763-951-8235, or e-mail [email protected].
Quantity in commerce: 2
Distribution: US: IN, MI, TX. OUS: GERMANY, FRANCE, ITALY, SWITZERLAND.
Product codes and lots: 6307760001

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1882-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1882-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-08	2016-06-01
Z-1883-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-08	2016-06-01
Z-1884-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-08	2016-06-01

Product code HWE

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)