Z-1884-2016Class II

Torque Limiting Adapter: Torque Limiting Attachment, Non Sterile, Distributed by Zimmer. PRECIMED, Torque...

Name: Z-1884-2016 Torque Limiting Adapter: Torque Limiting Attachment, Non Sterile, Distributed by Zimmer. PRECIMED, Torque...
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 Adapter: Torque Limiting Attachment, Non Sterile, Distributed by Zimmer. PRECIMED, Torque Limiting Adaptor, Non Sterile.. Customer... 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-1884-2016
Classification: Class II
Status: Terminated
Initiated: 2016-04-26
Posted: 2016-06-01
Terminated: 2018-06-07
Recalling firm: Greatbatch Medical
Product: Torque Limiting Adapter: Torque Limiting Attachment, Non Sterile, Distributed by Zimmer. PRECIMED, Torque Limiting Adaptor, Non Sterile.. Customer Number/Model: 00-2360-080-00 T10232, T116245 T116245, TLA025-25 TLA025-25, 00-2360-080-05 T10233, MAC21003 T116430, TLA025-30 TLA025-30, MAC21001 T112972, MAC21001 T13621, TLA025-20 TLA025-20.
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: 5952
Distribution: US: IN, MI, TX. OUS: GERMANY, FRANCE, ITALY, SWITZERLAND.
Product codes and lots: 1000207 1001049 1001048 1000698 1000582 1000582 1001334 1001334 1002457 1002456 1002974 1002640 1003175 1003174 1003223 1003223 1003224 1003225 1003548 1003766 1003908 1004435 1004485 1004349 1004903 1005099 1004347 1005530 1005772 1005900 1009013 1008458 1009195 1009195 1009197 1009014 1009198 1009196 1009698 1009199 1009699 1009200 1009700 1011763 1010602 1012455 1012490 1013172 1013173 1013415 1013416 1013921 1013922 1514611 1614605 1714700 1953758 1953809 1953810 2124866 2073128 2116179 2141896 1953758 2150164 2157328 2209891 2302780 2302777 2302781 2302788 2362691 2407040 2407047 2407040 2407040 2898285 2898285 2898289 2971943 2904251 2919512 2938191 2978582 1004138 1004139 1004413 1004578 1004577 1004580 1004579 1005899 1005817 1009701 2324706 2920624 3092836 3092836 1006939 FC-002 FC-002 1012458 6280900001 8027435 8027436 8027434

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1884-2016
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)