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
403486421850423482423498424916 459230459967459990460697462208465157465212470140471013471021471022471031471046471048471060471102471109471120 4721254732604732954754784754884773154778664778864783184783384790794796704796734798214798284804654817454840114855114855574855674855914856224856564856604856694861124861384861424861504895684899574899624899794900764900864900884907581992710
- Lot Codes for Model CTR73
180 of 180 codes
3369234234824234984599964667894684744699564710314710484710604710674710824711094711204711264711314711354711364721254730404761264761584761904796734821374826924855064855914861424861434866184899574900764900864907581997327199733620008482001693200170520264202026431203514020351552035867203590820391312039149204290820429122043698204370120437172043738204696720478152047827204896620493612053014
- Lot Codes for Model CTR03
- 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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