Recall Z-1835-2015
Stryker Sustainability Solutions · initiated June 1, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: Lot Codes for Model CTR03: 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, 1993479, 1997304, 1997315, 2000830, 2013237, 2014811, 2026372, 2026386, 2026408, 2035129, 2035138, 2035851, 2039108, 2039112 ,2047804, 2048945, 2049374, 2057081, 2060309, 2069618, 2070535, 2070588, 2071279, 2072131, 2100350, 2100378, 2111413, 2111421, 2114563, 2114585, 2114592, 2128288, 2128290, 2133045, 2134884, 2163528, 2175866, 2201534, 2201547, 2203131, 2203371, 2203562, 2208579, 2209452, 2209475, 2230529, 2232962, 2234218, 2236956, 2239309, 2241486, 2243783, 2244669, 2246728, 2248717, 2250745, 2252614, 2255994, 2259037, 2259059, 2261294, 2261304, 2261315, 2263727, 2263736, 2263743, 2265643, 2265658, 2265670, 2267530, 2267553, 2269653, 2269669, 2270325, 2271178…
Reason for recall
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.
FDA-determined cause: Under Investigation by firm
Action taken
On 06/01/15 a customer notification letter was sent out by the firm. The notification letter instructs customers to stop using the affected lots of the recalled product, and should consider other trocar models reprocesses by Stryker as an alternative. The letter notes that attached is a Effectiveness Check Form and complete list of affected lots shipped to the facility. A Stryker Sustainability Solutions Sales Representative will be sent to check the inventory of the affected lots. Once the inventory is checked the affected lots will be removed. The firm will complete a Recall Effectiveness Check Form . The form is to be completed even if no affected product is found. The firm requests that the form be returned to the sales representative or fax to 480-809-4975. If the form indicates that affected devices remain in inventory a prepaid shipping label will be issued for the return of the product. Customers will receive a credit for all affected devices returned. The firm states that adverse reactions or quality problems experiences with the use of the product may be reported to the firm's hotline 888-888-3433 x5572, or at www.stryker.com/productexperience as well as through FDA's MedWatch Adverse Event Reporting program.
Details
- Recall number
- Z-1835-2015
- Initiated
- June 1, 2015
- Posted by FDA
- June 25, 2015
- Terminated
- August 16, 2016
- Product code
- NLM – Laparoscope, General & Plastic Surgery, Reprocessed
- Quantity
- 147,351
- Distribution
- Distributed Nationwide including Puerto Rico.
- Recalling firm
- Stryker Sustainability Solutions, Tempe, AZ
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1834-2015 Class II | Fios First Entry; 5mm x 100mm and 12mm x 100mm; Model #:CTF03 and CTF73. Indicated for…Stryker Sustainability Solutions is recalling Trocars because they have received reports indicating that… | 06/01/2015Terminated |
| Z-1836-2015 Class II | Cannula and Seal; 5mm x 100mm and 12mm x 100mm Model #: CTS02 and CTS22. Indicated for…Stryker Sustainability Solutions is recalling Trocars because they have received reports indicating that… | 06/01/2015Terminated |