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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 73948

3 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
April 26, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Greatbatch Medical

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

3 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 3

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.

Z-1882-2016
Recall number
Z-1882-2016
Initiated
April 26, 2016
Classification
Class II
Status
Terminated
Recalling firm
Greatbatch Medical
Quantity
2

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

6307760001

Distribution pattern

US: IN, MI, TX. OUS: GERMANY, FRANCE, ITALY, SWITZERLAND.

device · product 2 of 3

Torque Limiting Screwdriver: Greatbatch Medical, Torque Limiting Driver, Non Sterile, Rx Only. PRECIMED, Non Sterile. Zimmer, Non Sterile, Rx Only. Screwdriver: Customer Number/Model: 804-03-038 T11623, T14001 T14001, MTO35173507 T14378, MTO375173506 T14379, MTO35173505 T14380, MTO35175303 T8127.

Z-1883-2016
Recall number
Z-1883-2016
Initiated
April 26, 2016
Classification
Class II
Status
Terminated
Recalling firm
Greatbatch Medical
Quantity
1110

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

2743160001 6091900001 3035180001 NOT AVAILABLE 6245730001 6245740001 6245750001 6245760001 6245770001 6245780001 6245790001 6245800001 6245810001 6245820001 6245830001 6245840001 6245850001 6245860001 6245870001 6245880001 6245890001 6245900001 6245910001 6245920001 6245930001 6245940001 6245950001 6245960001 6245970001 6245980001 6245990001 6246000001 6246010001 6246020001 6246030001 6246040001 6246050001 6246060001 6246070001 6246080001 6246090001 6246100001 6246110001 6246120001 6246130001 6246140001 6246150001 6246160001 6246170001 6246180001 6246190001 6246200001 6246210001 6246220001 6292870001 6420330001 6420340001 6422470001 6422480001 6422490001 6422500001 6422510001 6422520001 6422530001 6422540001 6422550001 6422560001 6441490001 6441500001 6448220001 6448230001 6448240001 6448250001 6448260001 6448270001 6448280001 6448290001 6448300001 6448310001 2091662 2091663 2091664 2091665 2091666 2091667 2091668 2091669 2091670 2091671 2091672 2091673 2091674 2091675 2091676 2091678 2091679 2091680 2091681 2091683 2091684 2091685 2091686 2091687 2091688 2091689 2091690 2091691 2091692 2091693 2091694 2091695 2091696 2091697 2091698 2091699 2091700 2091701 2091702 2091703 2091704 2091705 2091706 2091707 2091708 2091709 2091710 2091711 2091712 2169560 87437L01 87437L02 87437L03 87437L04 87437L05 87437L06 87437L07 87437L08 87437L09 87437L10 87437L11 87437L12 87437L13 87437L14 87437L15 87437L16 87437L17 87437L18 87437L19 87437L20 87437L21 87437L22 87437L23 87437L24 87437L25 87437L26 87437L27 87437L28 87437L29 87437L30 87437L31 87437L32 87437L33 87437L34 87437L35 87437L36 87437L37 87437L38 87437L39 87437l40 2367006 2367007 2367005 2367004 2367003 2367030 2367009 2367031 2367027 2367024 2367022 2367021 2367020 2367019 2367017 2367016 2367015 2367013 2367012 2367010 2367001 2366998 2366994 2366990 2366982 2366979 2366976 2366974 2366971 2366938 2366936 2366935 2366933 2366927 2366926 2366925 2366923 2366920 2366903 2366888 2461535 2461536 2461537 2461538 2461539 2461540 2461541 2461542 2461543 2461544 2461545 2461546 2461547 2461548 2461549 2461550 2461551 2461552 2461553 2461554 2461555 2461556 2461557 2461558 2461559 2461560 2461561 2461562 2461563 2461564 2461566 2461567 2461568 2461569 2461570 2461571 2461572 2461573 2461574 2461575 2461576 2461577 2461578 2461579 2461580 2461581 2461582 2461583 2461584 2461585 2702426 2933269 3053518 3053546 3053554 4046090001 7117840001 7117850001 6359420001 6404150001 6422990001 6464740001 7117860001 "05.1587814 05.1438412 05.1521913

Distribution pattern

US: IN, MI, TX. OUS: GERMANY, FRANCE, ITALY, SWITZERLAND.

device · product 3 of 3

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.

Z-1884-2016
Recall number
Z-1884-2016
Initiated
April 26, 2016
Classification
Class II
Status
Terminated
Recalling firm
Greatbatch Medical
Quantity
5952

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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

Distribution pattern

US: IN, MI, TX. OUS: GERMANY, FRANCE, ITALY, SWITZERLAND.