Z-0060-2017 Class II Terminated
FDA device recall Z-0060-2017 was initiated by Stryker Howmedica Osteonics Corp. on August 18, 2016 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated August 1, 2018). Affected quantity: 3,768 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 19, 2016
- Initiation Date
- August 18, 2016
- Termination Date
- August 1, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,768 units
Product Description
Stryker Orthopaedics Universal Acetabular Cup Positioner/Impactor, REF 2101-0200, Non-Sterile, Howmedica Osteonics Corp., Mahwah, NJ, USA, A Subsidiary of Stryker Corp.
Reason for Recall
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.
Distribution Pattern
US and Internationally
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