Device product
CODMAN Disposable Perforator 11mm. Cranial Perforator.
Z-0373-2026
Product summary
- Event
- Event 97623
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 16,251 units
- Official record key
device-enforcement:Z-0373-2026
Official wording
Reason: Expansion of recall of size 14 mm Codman Disposable Perforators for inadequate welds to size 11 mm and 9 mm Codman Disposable Perforators out of an abundance of caution.
Code information: Model No. 261222; UDI: 10381780513612; Lot No. 7221964, 7221972, 7221976, 7221977, 7221978, 7221979, 7221980, 7221981, 7221982, 7221983, 7221984, 7221985, 7221986, 7221987, 7221988, 7221989, 7221990, 7221991, 7230624, 7230625, 7230626, 7230627, 7230628, 7230629, 7230630, 7230631, 7230632, 7230633, 7230634, 7230635, 7230636, 7230637, 7230638, 7230639, 7230640, 7230641, 7230642, 7230643, 7230644, 7230645, 7230646, 7230647, 7230648, 7230649, 7230650, 7230651, 7230652, 7230653, 7230654, 7230655, 7230656, 7230657, 7230658, 7230659, 7230660, 7230661, 7282989, 7282990, 7282991, 7282992, 7282993, 7282994, 7282995, 7282996, 7282997, 7282998, 7282999, 7283000, 7283001, 7283002, 7283003, 7283004, 7283005, 7283006, 7283007, 7293432, 7293433, 7293434, 7293435, 7293436, 7293437, 7293438, 7293439, 7293440, 7293441, 7293442, 7293443, 7293444, 7293445, 7293446, 7293447, 7293448, 7293450, 7308709, 7308710, 7293449, 7293451, 7308706, 7308707, 7308708, 7308711, 7308712, 7308713, 7308714, 7308715, 7322887, 7322888, 7322889, 7322890, 7322891, 7323305, 7323306, 7323307, 7323308, 7323309, 7332669, 7332670, 7332671, 7332672, 7332673, 7332674, 7332675, 7332676, 7332677, 7348757, 7348758, 7348759, 7348760, 7348761, 7348762, 7348763, 7348764, 7348765, 7348766, 7348767, 7348768, 7348769, 7348770, 7348771, 7348772, 7348773, 7348774, 7348775, 7348776, 7348777, 7348778, 7348779, 7348780, 7348781, 7348782, 7371090, 7371091, 7371092, 7371093, 7371094, 7371095, 7371096, 7371097, 7371098, 7371099, 7371100, 7371101, 7371102, 7371103, 7387974, 7387975, 7387976, 7387977, 7387978, 7387979, 7387980, 7387981, 7387982, 7387983, 7387984, 7387985, 7387986, 7387987, 7387991, 7402327, 7402328, 7402329, 7402330, 7402331, 7402332, 7402333, 7402334, 7406854, 7406855, 7406856, 7406857, 7406858, 7406859, 7406860, 7406861, 7448431, 7448432, 7448433, 7448434; Expiration Date: 2028-04-30 to 2029-07-31.
Distribution pattern: Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Bahamas, Barbados, Belgium, Brazil, Canada, Chile, Colombia, Cyprus, Czechia, Ecuador, France, French Guiana, Germany, Greece, India, Ireland, Italy, Japan, Jordan, Korea, Lithuania, Mexico, Morrocco, Netherlands, New Zealand, Palestine, State of, Philippines, Portugal, Puerto Rico, Qatar, Republic of North Macedonia, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan , Thailand, Trinidad and Tobago, Tunisia, Turkey, United Arab Emirates, United Kingdom of Great Britain and Northern Ireland, Vietnam.
Derived failure modes
-
Unknown
Expansion of recall of size 14 mm Codman Disposable Perforators for inadequate welds to size 11 mm and 9 mm Codman Disposable Perforators out of an abundance of caution.