Reported Mar 23, 2016 · Terminated

Product 53 consists of all product under: product code: JWH and same usage: Item no: 597002501 NEXGEN PRECOAT PEG TIB…

Zimmer Manufacturing B.V.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Zimmer Manufacturing B.V. · Turpeaux Industrial Park Rd 1 km 123.4 · Mercedita, PR · 00715

Is this the product you have?

  • Product 53
  • consists of all product underproduct
  • codeJWH
  • and same usageItem
  • no597002501 NEXGEN PRECOAT PEG TIB PL 597002502 NEXGEN PRECOAT PEG TIB PL 597003501 NEXGEN PRECOAT PEG TIB PL 597003502 NEXGEN PRECOAT PEG TIB PL 597004501 NEXGEN PRECOAT PEG TIB PL 597004502 NEXGEN PRECOAT PEG TIB PL 597005501 NEXGEN PRECOAT PEG TIB PL 597005502 NEXGEN PRECOAT PEG TIB PL 597005503 NEXGEN PRECOAT PEG TIB PL 597005504 NEXGEN PRECOAT PEG TIB PL 598002701 NEXGEN PRECOAT STEMMED TI 598002702 NEXGEN PRECOAT STEMMED TI 598003701 NEXGEN PRECOAT STEMMED TI 598003702 NEXGEN PRECOAT STEMMED TI 598004701 NEXGEN PRECOAT STEMMED TI 598004702 NEXGEN PRECOAT STEMMED TI 598005701 NEXGEN PRECOAT STEMMED TI 598005702 NEXGEN PRECOAT STEMMED TI 598005703 NEXGEN PRECOAT STEMMED TI 598005704 NEXGEN PRECOAT STEMMED TI 598801510 NEXGEN SHARP FLUTED STEM 598801511 NEXGEN SHARP FLUTED STEM 598801512 NEXGEN SHARP FLUTED STEM 598801513 NEXGEN SHARP FLUTED STEM 598801514 NEXGEN SHARP FLUTED STEM 598801515 NEXGEN SHARP FLUTED STEM 598801516 NEXGEN SHARP FLUTED STEM 598801517 NEXGEN SHARP FLUTED STEM 598801518 NEXGEN SHARP FLUTED STEM 598801519 NEXGEN SHARP FLUTED STEM 598801520 NEXGEN SHARP FLUTED STEM 598801010 NEXGEN STRAIGHT STEM EXT 598801011 NEXGEN STRAIGHT STEM EXT 598801012 NEXGEN STRAIGHT STEM EXT 598801013 NEXGEN STRAIGHT STEM EXT 598801014 NEXGEN STRAIGHT STEM EXT 598801015 NEXGEN STRAIGHT STEM EXT 598801016 NEXGEN STRAIGHT STEM EXT 598801017 NEXGEN STRAIGHT STEM EXT 598801018 NEXGEN STRAIGHT STEM EXT 598801020 NEXGEN STRAIGHT STEM EXT 598801022 NEXGEN STRAIGHT STEM EXT 598801024 NEXGEN STRAIGHT STEM EXT 598801112 NEXGEN STRAIGHT STEM EXT 598801113 NEXGEN STRAIGHT STEM EXT 598801114 NEXGEN STRAIGHT STEM EXT 598801115 NEXGEN STRAIGHT STEM EXT 598801116 NEXGEN STRAIGHT STEM EXT 598801117 NEXGEN STRAIGHT STEM EXT 598801118 NEXGEN STRAIGHT STEM EXT 598801212 NEXGEN STRAIGHT STEM EXT 598801215 NEXGEN STRAIGHT STEM EXT for use in total knee arthroplasty
Lot codes and dates
  • lot no.:

    3,260 of 3,260 codes

    • 61797104
    • 61797098
    • 61797099
    • 61823441
    • 61958847
    • 61963895
    • 62029932
    • 62029933
    • 62130571
    • 62130703
    • 62190529
    • 62261995
    • 62261996
    • 62298547
    • 61809090
    • 61809091
    • 61809092
    • 61809094
    • 61809095
    • 61816526
    • 61816527
    • 61816528
    • 61816529
    • 61823442
    • 61823443
    • 61830085
    • 61830086
    • 61830087
    • 61869782
    • 61869783
    • 61869784
    • 61905813
    • 61905814
    • 61905815
    • 61905816
    • 61918789
    • 61926794
    • 61926795
    • 61926796
    • 61947456
    • 61947457
    • 61947458
    • 61967928
    • 61967929
    • 61984965
    • 61984966
    • 61984967
    • 62051520
    • 62082119
    • 62082120
    • 62082121
    • 62098807
    • 62115643
    • 62115644
    • 62115645
    • 62130131
    • 62159766
    • 62159767
    • 62159768
    • 62168172
Amount recalled
202221

This recall covers 72 products

The agency filed one notice per product. You are reading one of them; the other 71 are below.

59 more are in the archive.

Where it was sold

  • Nationwide

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Apr 13, 2017 · Data as of Sep 19, 4:47 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.