Class 2 Device Recall SafeLight Fiber Optic Cable: Clear, 5MM X 10FT 3.05M, REF: 0233050100; Gray, 5MM X 10FT 3.05M, REF

• Date Initiated by Firm: March 02, 2023
• Date Posted: April 28, 2023
• Recall Status: Open, Classified
• Recall Number: Z-1474-2023
• Recall Event ID: 91891
• 510(K)Number: K082813
• Product Classification: Light source, fiberoptic, routine - Product Code FCW
• Product: SafeLight Fiber Optic Cable: Clear, 5MM X 10FT 3.05M, REF: 0233-050-100; Gray, 5MM X 10FT 3.05M, REF: 0233-050-200
• Code Information: Ref/UDI-DI/Lot: 0233-050-100/07613327051650/159190, 159191, 159192, 159194, 159195, 159196, 159197, 159198, 159199, 159200, 159201, 159202, 159203, 159204, 159205, 159206, 159207, 159208, 159209, 159210, 159211, 159212, 159213, 159214, 159215, 159216, 159217, 159218, 164764, 164765, 164766, 164767, 164768, 164769, 164770, 164771, 164772, 164773, 164774, 164775, 164776, 164777, 164778, 164779, 164780, 164781, 164782, 164783, 164784, 164785, 164786, 164787, 164788, 164789, 164790, 164791, 164792, 164793, 164794, 164795, 164796, 164797, 164798, 164799, 164800, 164801, 164802, 164803, 164804, 164805, 164806, 164807, 164808, 164809, 164810, 164811, 164812, 164813, 164814, 164815, 164816, 164817, 164818, 164819, 164820, 164821, 164822, 168940, 168941, 168942, 168943, 168944, 168945, 168946, 168947, 168948, 168949, 168950, 168951, 168952, 168953, 168954, 168955, 168956, 168957, 168958, 168959, 168960, 168961, 168962, 168963, 168964, 168965, 168966, 168967, 168968, 168969, 168970, 168971, 168972, 168973, 168974, 168975, 168976, 168977, 168978, 168979, 168980, 168981, 168987; 0233-050-200/07613327051643/158865, 158868, 158869, 158872, 158874, 158875, 158878, 158884, 165446, 165448, 165451, 165457, 165458, 165459, 165461, 165462, 165464, 168909, 168910, 168911, 168912, 168913, 168914, 168915, 168916, 168917, 168918, 168919, 168920, 168921, 168923, 168924, 168925, 168926, 168927, 168928
• FEI Number: 2936485
• Recalling Firm/ Manufacturer: Stryker Corporation; 5900 Optical Ct; San Jose CA 95138-1400
• For Additional Information Contact: 408-754-2000
• Manufacturer Reason for Recall: Fiber optic cables assembled with not enough epoxy on the proximal end, creating light output issues, which could cause a clinical delay or procedure being converted to open.
• FDA Determined Cause: Employee error
• Action: On 3/2/23 recall notices were mailed to customers who were asked to do the following: 1. Inform individuals within your organization who need to be aware of this action. 2. Identify, remove, and quarantine affected devices. 3. If affected product is found, call customer service at 1-800-624-4422 (Option 3) or email endocustomersupport@stryker.com to arrange for product return. 4. Complete and return the Business Reply Form Customers with questions can contact EndoRecall@stryker.com
• Quantity in Commerce: 5,228
• Distribution: Worldwide - US Nationwide distribution including in the states of PA, MS, IL, OH, CA, TX, MO, IN, KS, OK, MT, MA, NE, AZ, NV, NJ, IA, WV, MD, KY, FL, NM, NY, CO, WA, NC, VA, LA, ND, WY, HI SC, UT, OR, SD, AR, TN, AK, CT, GA, ID, VT, NH, MN, WI, DE, RI, AL, MI and the countries of NL, PE, AT, CA, TW, PH, SG, KR, CN.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = FCW