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U.S. Department of Health and Human Services

Class 2 Device Recall Trident Universal Impactor/Positioner

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  Class 2 Device Recall Trident Universal Impactor/Positioner see related information
Date Initiated by Firm August 18, 2016
Date Posted October 07, 2016
Recall Status1 Terminated 3 on August 01, 2018
Recall Number Z-0060-2017
Recall Event ID 75077
510(K)Number K153345  
Product Classification Impactor - Product Code HWA
Product Stryker Orthopaedics Universal Acetabular Cup Positioner/Impactor, REF 2101-0200, Non-Sterile, Howmedica Osteonics Corp., Mahwah, NJ, USA, A Subsidiary of Stryker Corp.
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
Recalling Firm/
Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430-2006
Manufacturer 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.
FDA Determined
Cause 2
Nonconforming Material/Component
Action Stryker sent an Urgent Medical Device Recall Notification dated August 18, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Actions Needed: 1. Please inform users of this Urgent Medical Device Recall and forward this notice to all those individuals who need to be aware within your organization. 2. Branches/Agencies: Return all affected products available at your location to Stryker C/0 Stericycle 3. Hospitals/Branches: Complete and sign the enclosed Business Reply Form and fax a copy to 877-546-0444 or email to Stericycle strvkerortho6536@stericycle.com. Our records indicate that you have received the above referenced instrument. It is our responsibility to ensure that customers who may have received this affected instrument also receive this important communication. Please assist us in meeting our regulatory obligation by faxing back the attached Business Reply Form within 5 days. We regret any inconvenience this action may cause you and if you have any questions, feel free to contact me at (201) 831-6693. For further questions regarding this recall, please call (201) 831-5000.
Quantity in Commerce 3,768 units
Distribution US and Internationally
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HWA and Original Applicant = STRYKER ORTHOPAEDICS