Reported Mar 23, 2016 · Terminated

Product 23 consists of all product code: JDI and same usage: Item no: 801100220 CPT 2 HIP STEM, X-OFFSET 801100320 CPT…

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 23 consists of all product codeJDI
  • and same usageItem
  • no801100220 CPT 2 HIP STEM, X-OFFSET 801100320 CPT 3 HIP STEM, X-OFFSET 801100420 CPT 4 HIP STEM, X-OFFSET 801100005 CPT HIP STEM PETITE 801100700 CPT HIP STEM SZ 2 LONG 801100800 CPT HIP STEM SZ 3 LONG 801100222 CPT MOD HD ST/ST 22MED SH 801100322 CPT MOD HD ST/ST 22MMD LN 801100122 CPT MOD HD ST/ST 22MMD SH 801100126 CPT MOD HD ST/ST 26MMD SH 801100328 CPT MOD HD ST/ST 28MMD LN 801100228 CPT MOD HD ST/ST 28MMD ME 801100128 CPT MOD HD ST/ST 28MMD SH 801100332 CPT MOD HD ST/ST 32MMD LN 801100232 CPT MOD HD ST/ST 32MMD ME 801100132 CPT MOD HD ST/ST 32MMD SH 801100100 CPT MODULAR STEM SIZE 1 S 801100200 CPT MODULAR STEM SIZE 2 S 801100300 CPT MODULAR STEM SIZE 3 S 801100400 CPT MODULAR STEM SIZE 4 S 801100500 CPT MODULAR STEM SIZE 5 S For use in total or hemi hip arthroplasty
Lot codes and dates
  • lot no.:

    435 of 435 codes

    • 61882616
    • 62030937
    • 62087634
    • 62154310
    • 62264269
    • 62312479
    • 62264269N
    • 62033232
    • 62097081
    • 62264270
    • 62303492
    • 62097082
    • 62264271
    • 62324103
    • 62264271N
    • 61833317
    • 61936207
    • 61942441
    • 61955618
    • 61964737
    • 62024630
    • 62024632
    • 62028824
    • 62028826
    • 62028827
    • 62028828
    • 62041514
    • 62041515
    • 62041516
    • 62042594
    • 62042595
    • 62043475
    • 62094958
    • 62094959
    • 62103574
    • 62103575
    • 62105196
    • 62105197
    • 62106789
    • 62118981
    • 62121273
    • 62121274
    • 62122111
    • 62148550
    • 62148551
    • 62240713
    • 62249029
    • 62255999
    • 62284453
    • 62094958N
    • 62094959N
    • 62103574N
    • 62105196N
    • 62105197N
    • 62118981N
    • 62121273N
    • 62121274N
    • 62122111N
    • 62148550N
    • 62148551N
Amount recalled
10

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, 5:20 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.