Data Foundry

Medical device recalls 2016

Product 42 consists of all product under product code: HSB and same… — Class II medical device recall Z-1140-2016

Terminated recall by Zimmer Manufacturing B.V., reported 2016-03-23, distributed nationwide. As a result of the insufficient sealer calibration data for product packaged in firm's Building II between Aug

Recall numberZ-1140-2016
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmZimmer Manufacturing B.V., Mercedita, PR, United States
Recall initiated2016-01-11
Classified2016-03-12
Reported by FDA2016-03-23
Terminated2017-04-13
DistributedNationwide (US)
Quantity1,622
Reason classessterility
Lot numbers370497, 370498, 370505, 370506, 370507, 370508, 370509, 370510, 370511, 370512, 370513, 370520, 370523, 370526, 370532, 370538, 370562, 370564, 370565, 370568, 370570, 370571, 370587, 370593, 370597, 370598, 370599, 370603, 370610, 370667, 370702, 370703, 370704, 370705, 370706, 370707, 370708, 370709, 370710, 370711 and 460 more
Model numbers225224010

Product

Product 42 consists of all product under product code: HSB and same usage: Item no: 225224010 M/DN FEM IM NAIL 10MM DIA 225228010 M/DN FEM IM NAIL 10MM DIA 225230010 M/DN FEM IM NAIL 10MM DIA 225232010 M/DN FEM IM NAIL 10MM DIA 225234010 M/DN FEM IM NAIL 10MM DIA 225236010 M/DN FEM IM NAIL 10MM DIA 225238010 M/DN FEM IM NAIL 10MM DIA 225240010 M/DN FEM IM NAIL 10MM DIA 225242010 M/DN FEM IM NAIL 10MM DIA 225244010 M/DN FEM IM NAIL 10MM DIA 225246010 M/DN FEM IM NAIL 10MM DIA 225228011 M/DN FEM IM NAIL 11MM DIA 225230011 M/DN FEM IM NAIL 11MM DIA 225232011 M/DN FEM IM NAIL 11MM DIA 225234011 M/DN FEM IM NAIL 11MM DIA 225236011 M/DN FEM IM NAIL 11MM DIA 225238011 M/DN FEM IM NAIL 11MM DIA 225240011 M/DN FEM IM NAIL 11MM DIA 225242011 M/DN FEM IM NAIL 11MM DIA 225244011 M/DN FEM IM NAIL 11MM DIA 225246011 M/DN FEM IM NAIL 11MM DIA 225224012 M/DN FEM IM NAIL 12MM DIA 225232012 M/DN FEM IM NAIL 12MM DIA 225234012 M/DN FEM IM NAIL 12MM DIA 225236012 M/DN FEM IM NAIL 12MM DIA 225238012 M/DN FEM IM NAIL 12MM DIA 225240012 M/DN FEM IM NAIL 12MM DIA 225242012 M/DN FEM IM NAIL 12MM DIA 225244012 M/DN FEM IM NAIL 12MM DIA 225246012 M/DN FEM IM NAIL 12MM DIA 225228013 M/DN FEM IM NAIL 13MM DIA 225230013 M/DN FEM IM NAIL 13MM DIA 225232013 M/DN FEM IM NAIL 13MM DIA 225234013 M/DN FEM IM NAIL 13MM DIA 225236013 M/DN FEM IM NAIL 13MM DIA 225238013 M/DN FEM IM NAIL 13MM DIA 225240013 M/DN FEM IM NAIL 13MM DIA 225242013 M/DN FEM IM NAIL 13MM DIA 225244013 M/DN FEM IM NAIL 13MM DIA 225246013 M/DN FEM IM NAIL 13MM DIA 225236014 M/DN FEM IM NAIL 14MM DIA 225238014 M/DN FEM IM NAIL 14MM DIA 225240014 M/DN FEM IM NAIL 14MM DIA 225242014 M/DN FEM IM NAIL 14MM DIA 225244014 M/DN FEM IM NAIL 14MM DIA 225246014 M/DN FEM IM NAIL 14MM DIA 225234015 M/DN FEM IM NAIL 15MM DIA 225240015 M/DN FEM IM NAIL 15MM DIA 225242015 M/DN FEM IM NAIL 15MM DIA 225244015 M/DN FEM IM NAIL 15MM DIA 225242016 M/DN FEM IM NAIL 16MM DIA 225230008 M/DN FEM IM NAIL 8MM DIA 225232008 M/DN FEM IM NAIL 8MM DIA 225234008 M/DN FEM IM NAIL 8MM DIA 225238008 M/DN FEM IM NAIL 8MM DIA 225228009 M/DN FEM IM NAIL 9MM DIA 225230009 M/DN FEM IM NAIL 9MM DIA 225232009 M/DN FEM IM NAIL 9MM DIA 225234009 M/DN FEM IM NAIL 9MM DIA 225236009 M/DN FEM IM NAIL 9MM DIA 225238009 M/DN FEM IM NAIL 9MM DIA 225240009 M/DN FEM IM NAIL 9MM DIA 225242009 M/DN FEM IM NAIL 9MM DIA 225244009 M/DN FEM IM NAIL 9MM DIA 225418010 M/DN HUMERAL I/M NAIL 10M 225419510 M/DN HUMERAL I/M NAIL 10M 225421010 M/DN HUMERAL I/M NAIL 10M 225422510 M/DN HUMERAL I/M NAIL 10M 225424010 M/DN HUMERAL I/M NAIL 10M 225425510 M/DN HUMERAL I/M NAIL 10M 225427010 M/DN HUMERAL I/M NAIL 10M 225428510 M/DN HUMERAL I/M NAIL 10M 225430010 M/DN HUMERAL I/M NAIL 10M 225419511 M/DN HUMERAL I/M NAIL 11M 225421011 M/DN HUMERAL I/M NAIL 11M 225422511 M/DN HUMERAL I/M NAIL 11M 225424011 M/DN HUMERAL I/M NAIL 11M 225425511 M/DN HUMERAL I/M NAIL 11M 225427011 M/DN HUMERAL I/M NAIL 11M 225421012 M/DN HUMERAL I/M NAIL 12M 225422512 M/DN HUMERAL I/M NAIL 12M 225424012 M/DN HUMERAL I/M NAIL 12M 225425512 M/DN HUMERAL I/M NAIL 12M 225427012 M/DN HUMERAL I/M NAIL 12M 225428512 M/DN HUMERAL I/M NAIL 12M 225430012 M/DN HUMERAL I/M NAIL 12M 225418013 M/DN HUMERAL I/M NAIL 13M 225424013 M/DN HUMERAL I/M NAIL 13M 225427013 M/DN HUMERAL I/M NAIL 13M 225418006 M/DN HUMERAL I/M NAIL 6MM 225419506 M/DN HUMERAL I/M NAIL 6MM 225421006 M/DN HUMERAL I/M NAIL 6MM 225424006 M/DN HUMERAL I/M NAIL 6MM 225427006 M/DN HUMERAL I/M NAIL 6MM 225428506 M/DN HUMERAL I/M NAIL 6MM 225430006 M/DN HUMERAL I/M NAIL 6MM 225418007 M/DN HUMERAL I/M NAIL 7MM 225419507 M/DN HUMERAL I/M NAIL 7MM 225421007 M/DN HUMERAL I/M NAIL 7MM 225422507 M/DN HUMERAL I/M NAIL 7MM 225424007 M/DN HUMERAL I/M NAIL 7MM 225425507 M/DN HUMERAL I/M NAIL 7MM 225427007 M/DN HUMERAL I/M NAIL 7MM 225428507 M/DN HUMERAL I/M NAIL 7MM 225430007 M/DN HUMERAL I/M NAIL 7MM 225418008 M/DN HUMERAL I/M NAIL 8MM 225

Reason for recall

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1140-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.