Reported Jul 1, 2015 · Terminated

Optical Access System; 5mm x 100mm and 12mm x 100mm; Model #: CTR03 and CTR73. Indicated for use to establish a port of…

Stryker Sustainability Solutions

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: Stryker Sustainability Solutions · 1810 W Drake Dr · Tempe, AZ · 85283-4327

Is this the product you have?

  • Optical Access System; 5mm x 100mm and 12mm x 100mm; Model #: CTR03 and CTR73. Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal procedures.
Lot codes and dates
  • Lot Codes for Model CTR03

    471 of 471 codes

    • 403486
    • 421850
    • 423482
    • 423498
    • 424916 459230
    • 459967
    • 459990
    • 460697
    • 462208
    • 465157
    • 465212
    • 470140
    • 471013
    • 471021
    • 471022
    • 471031
    • 471046
    • 471048
    • 471060
    • 471102
    • 471109
    • 471120 472125
    • 473260
    • 473295
    • 475478
    • 475488
    • 477315
    • 477866
    • 477886
    • 478318
    • 478338
    • 479079
    • 479670
    • 479673
    • 479821
    • 479828
    • 480465
    • 481745
    • 484011
    • 485511
    • 485557
    • 485567
    • 485591
    • 485622
    • 485656
    • 485660
    • 485669
    • 486112
    • 486138
    • 486142
    • 486150
    • 489568
    • 489957
    • 489962
    • 489979
    • 490076
    • 490086
    • 490088
    • 490758
    • 1992710
  • Lot Codes for Model CTR73

    180 of 180 codes

    • 336923
    • 423482
    • 423498
    • 459996
    • 466789
    • 468474
    • 469956
    • 471031
    • 471048
    • 471060
    • 471067
    • 471082
    • 471109
    • 471120
    • 471126
    • 471131
    • 471135
    • 471136
    • 472125
    • 473040
    • 476126
    • 476158
    • 476190
    • 479673
    • 482137
    • 482692
    • 485506
    • 485591
    • 486142
    • 486143
    • 486618
    • 489957
    • 490076
    • 490086
    • 490758
    • 1997327
    • 1997336
    • 2000848
    • 2001693
    • 2001705
    • 2026420
    • 2026431
    • 2035140
    • 2035155
    • 2035867
    • 2035908
    • 2039131
    • 2039149
    • 2042908
    • 2042912
    • 2043698
    • 2043701
    • 2043717
    • 2043738
    • 2046967
    • 2047815
    • 2047827
    • 2048966
    • 2049361
    • 2053014
Amount recalled
147,351

This recall covers 3 products

The agency filed one notice per product. You are reading one of them; the other 2 are below.

Where it was sold

  • Nationwide
  • PR

Why it was recalled

Stryker Sustainability Solutions is recalling Trocars because they have received reports indicating that some may fracture at the distal tip resulting in fragments at the surgical site.

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 Aug 16, 2016 · 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.