Device product
Stryker Orthopaedics Universal Acetabular Cup Positioner/Impactor, REF 2101-0200, Non-Sterile, Howmedica Osteonics Corp., Mahwah, NJ, USA, A Subsidiary of Stryker Corp.
Z-0060-2017
Product summary
- Event
- Event 75077
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3,768 units
- Official record key
device-enforcement:Z-0060-2017
Official wording
Reason: Stryker Orthopaedics has received reports of the thread length protruding past the dome of the acetabular trial or implant for the Trident Universal Impactor/Positioner.
Code information: Catalog No: 2101-0200, Lot Nos. SMM7A00, SMM7A00L, SMM7A02, SMM7A02A, SMM7A02E, SMM7A02EE, SMM7A01T, SMM7A01TT, SMM7A01TD, SMM7A01TDD, SMM7C02H, SMM7C02, SMM7C01, SMM7C01T, SMM7C01TT, SMM7C01W, SMM7E03, SMM7E03A, SMM7E00, SMM7A00E, SMM7E02, SMM7E02A, SMM7E01, SMM7E01A, SMM7K00. SMM7K01, SMM7K01A, SMM7K03, SMM7K03L, SMM7K02, SMM7K02T, SMM7K03X, SMM7K03Y, SMM7C02J, SMM7L00H, SMM7L00J, SMM7L00K, SMM7L00, SMM7C01TW, SMM7M01, SMM7A02T, SMM7M00, SMM7M00A, SMM7M02H, SMM7M02, SMM7E02M, SMM7E01JK, SMM7K03J, SMM7K00A, SMM6N04, SMM7N01J, SMM7N01, SMM7M06, SMM7M09, SMM7N03, SMM7N03A, SMM7M06A, SMM7M09, SMM7N00, SMM7M05, SMM7M08A, SMM7M10, SMM7N00A, SMM7N02L, SMM7M05J, SMM7M08, SMM7N02, SMM7N04, SMM7N04J, SMM8C00, SMM7M01R, SMM7M01RW, SMM7M01W, SMM7M07, SMM7M07J, SMM6C00, SMM7M03, SMM7M03A, SMM7M03D, SMM7M03E, SMM7M03L, SMM7M04, SMM7M04L, SMM7M03K, SMM8C00J, SMM8L05, SMM8L05A, SMM8L02X, SMM8L04, SMM6N00, SMM6N01, SMM6N01A, SMM6N02, SMM6N03, SMM6N04A, SMM8L07T, SMM8L08, SMM8M00K, SMM8M00L, SMM8M01, SMM8M01E, SMM8M01EE, SMM8N02, SMM8N02A, SMM8M01A, SMM8N00, SMM8N00A, SMM8N00D, SMM8N01, SMM8N01A, SMM8N01T, SMM8S00, SMM8S00T, SMM8S00TT, SMM8S01, SMM8S01A, SMM8S01D, SMM8T00, SMM8N02T, SMM8S02, SMM8V00, SMM8V00A, SMM8V00E, SMM8T00A, SMM8V01, SMM8V01A, SMM8W02, SMM8W03A, SMM8V02, SMM8W01, SMM8W01A, SMM8W02X, SMM8W03M, SMM8W03P, SMM8W04, SMM8W04A, SMM8W05, SMM8W05A, SMM8W03D, SMM8W03, SMM8W05D, SMM8W00A, SMM8W00E, SMM8W00J, SMM8W00K, SMM8W00, SMM8V02J, SMM8W00D, SMM8V07, SMM8W06H, SMM8W05H, SMM8W00H, SMM8W07, SMM8W07K, SMM8W07L, SMM8W08, SMM8W08E, SMM8W07A, SAMPLE25, SMM8W08EE, SMM9A00, SMM9A00R, SMM9A00T, SMM9A01, SMM9A01E, SMM9A01EL, SMM9A02, SMM9A02E, SMM9A03, SMM9A03K, SMM9A03L, SMM9A03P, SMM8L01, SMM8L03, SMM8L07, SMM8L00T, SMM8L07, SMM9A05, SMM9A06, SMM9A06E, SMM9A07, SMM9A08, SMM9A12, SMM9A12J, SMM9A12T, SMM9A09, SMM9A09K, SMM9A09L, SMM9A10, SMM9A11, SMM9A11D, SMM9A07L, SMM9E01, SMM9E02, SMM9E02A, SMM9E03, SMM9E00, SMM9C00A, SMM9C00D, SMM9C00, SMM9C00J, SMM9C00K, SMM9E05A, SMM9E04, SMM9E04A, SMM9E04D, SMM9E04E, SMM9E05, SMM9E04T, SMM9E04TT, SMM9E06, SMM9E06A, SMM9E06D, SMM9A03HD, SMM9A12X, SMM9H01, SMM9H01A, SMM9H01T, SMM8V01D, SMM8V05, SMM8V06, SMM8V04, SMM8V03, SMM9H00E, SMM9H00EE, SMM9H00K, SMM9H00L, SMM9H00V, SMM9K00, SMM9K01, SMM9K01AT, SMM9K01T, SMM8K01TT, SMM9K02A, SMM9K03, SMM9K02, SMM9K04, SMM9L00, SMM9L01, SMM9L02, SMM9L02A, SMM9L02E, SMM9L02M, SMM9L03, SMM9L03A, SMM9L03D, SMM9L03E, SMM9L04, SMM9L04D, SMM9L04E, SMM9L05, SMM9L04A, SMM9L07, SMM9L07A, SMM9L09, SMM9L09A, SMM9L09D, SMM9V00, SMM9V02A, SMM9V02D, SMM9V05, SMM9V07, SMM9V08A, SMM9A04, SMM9L09E, SMM9L10, SMM9L08, SMM9L08A, SMM9A09P, SMM9K01L, SMM9L06, SMM9M01L, SMM9M01, SMM9M01A, SMM9M03, SMM9M03A, SMMM03D, SMM9M03E, SMM0M02, SMM9M02A, SMM9M02L, SMM9M00, SMM9L10A, SMM9N02M, SMM9N02, SMM9N00, SMM9N00X, SMM9N00Y, SMM9N02K, SMM9N02J, SMM9N01, SMM9N01A, SMM9N01J, SMM9N05A, SMM09N05, SMM9N05D, SMM9N07J, SMM9H01K, SMM9N07JK, SMM9N07N, SMM9T01, SMMN9T01, SMM9T00, SMM0T00A, SMM9T02, SMM8V07A, SMM7E01T, SMM7K01AA, SMM0T00K, SMM9T00J, SMM9T03, SMM9T03A, SMM9T03D, SMM8W01AA, SMM9T03N, SMM9T03L, SMM9T03M, SMM8V01T, SMM8V07T, SMM8W00T, SMM8V03T, SMM8V05T, SMM8V07TT, SMM9V01, SMM9V01A, SMM9V01T, SMM9V01D, SMM9V01J, SMM9V01X, SMM9V00A, SMM9V08, SMM9V08AA, SMM09V06, SMM9V09J, SMM9V04, SMM9V09, SMM9V09A, SMM9V09K, SMM9V03, SMM9V02E, SMM9V02H, SMM9V02K, SMM9V09E, SMM9V09L, SMM9V09LE, SMM9V09LL, SMM9V00HJ, SMM9V00JH, SMM9V00H, SMM9N03, SMM9N04, SMM9N06, SMM9N06A, SMM9N07, SMM09N08, SMM9N08E, SMM9N07A, SMM9N07AA , SMM9N08A, SMM9N08D, SMM9N06T, SMM9N06TA and SMM9N07M
Distribution pattern: US and Internationally
Derived failure modes
-
Unknown
Stryker Orthopaedics has received reports of the thread length protruding past the dome of the acetabular trial or implant for the Trident Universal Impactor/Positioner.