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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker Orthopaedics

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  Class 2 Device Recall Stryker Orthopaedics see related information
Date Initiated by Firm August 15, 2014
Date Posted May 19, 2015
Recall Status1 Terminated 3 on January 05, 2018
Recall Number Z-1634-2015
Recall Event ID 70994
510(K)Number K962152  K974556  K042343  K030978  
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Product Stryker Orthopaedics Scorpio femoral component.
Howmedica Osteonics Corp., A subsidiary of Stryker Corporation Made in USA Sterile.

For use in total reconstructive replacement of the knee joint.
Code Information Item number 26-3005L Lot numbers MNH0ND, MNH3V7, MNH8XR, MNHN0E, MNH6Y5; 70-3003L Lot MNE6NM; 70-3003R Lot MNE963; 70-3007L Lots MNE58K, MNE6HL, MNE8MN, MNEKXP; 70-3007R Lots MNEV2Y, MNEVDV, MNEN3D, MNEX43; 70-3013L Lot MMMXTY; 70-4104L Lots MNE0Y8, MNE2J2, MND743, MNDVDT; 71-3009L Lots MNE12D, MNEALW, MNEEE4, MNEXLK, MNEXV0; 71-3009R Lots MNELHM, MNEYNE; 71-3013L Lot MMR24J; 71-4104L Lot MMAKXS; 71-4503R Lots MMT7P8, MMT8J3, MNDKJ7; 71-4504L Lots MNE5D4, MNEHV1; 71-4504R Lots MND272, MNDD9D, MNEL8W; 71-4505L Lots MMT4KY, MMTPHS, MNAJ78, MNAN2L, MNDP2N; 71-4505R Lots MMTEW1, MNA062, MNANVA; 71-4506L Lots MNAJ1W, MNARAR, MNEL1Y, MNEW53; 71-4507L Lots MMT971, MMT9R5X1, MMTJRT, MNALJA, MND1V8; 71-4507R Lots MNA17E, MND4WP, MNEAAD, MNEM55; 71-4509R Lots MMR2HL, MND9AE; 80-4403L Lots MNE0LE, MNEJ70, MNEK3L; 80-4404R Lot MNHTRK, 80-4405L Lot MNERD1; 80-4405R Lots MNEEND, MNEHNO, MNEK42, MNEMNR, MNEMXH, MNEY4A; 80-4406L Lots MNA4HR, MNEH40, MNE37L, MNE769, MNE9RD, MNEATP, MNEX06, MNEXA8; 80-4407R Lots MNELAL, MNEP9K, MNEPVE; 80-4408L Lot MNEX9T; 80-4409L Lots MNE7H9, MNEDWK, MNEDXN; 80-4409R Lots MNE0R2, MNETXP, MNEVTV; 80-4411L Lots MNEN81, MNEWN4; 80-6404R Lot MNDKD0; 80-6405R Lots MMTA8L, MNA175; 80-6407L Lot MMRV9D; 80-6411L Lot MMP7TS; 81-4404R Lots MNE34H, MNE9WN, MNEKY7; 81-4405L Lots MNE3XK, MNE4OR, MNE473, MNE50T, MNE6A5, MNE7NN, MNE9DD, MNEDX6, MNEJ0N, MNELK5, MNERR2; 81-4405R Lots MNE5PE, MNE5W5, MNEA1T, MNEH09, MNEK9M, MNEP17, MNEPET, MNEPX6, MNER3V, MNEWW7, MNEXDP, MNEXLL, MNEY3R; 81-4406L Lots MNE0J3, MNE5D6, MNEA42, MNEHL1, MNEM0H, MNEMD4, MNEMJ8, MNEMPD, MNENAR, MNEPN6, MNEW72; 81-4406R Lots MNE1XK, MNE5D2, MNEA75, MNED3A, MNEVLY, MNEYHH; 81-4407L Lots MNE127, MNE26L, MNE3KJ, MNE63T, MNE6XK, MNE71T, MNE8PT, MNE996, MNEPYY; 81-4407R Lots MMPE33, MNEOJ9, MNE217, MNE2NH, MNE3MH, MNE525, MNE5YP, MNE6WT, MNE7V2, MNE9J1, MNEA62, MNEAR2, MNEAXJ, MNED83, MNENNE, MNELEP, MNENM4, MNENY7, MNEPEP, MNERAV, MNETYX, MNEVN7, MNEW3Y, MNEW56, MNEWN0, MNEX5E, MNEXV1, MNEXVT, MNEY27, MNEYR6, MNHTW5; 81-4408L Lots MNE2VE, MNEAMY, MNEEM0, MNEYRT, MNEYYK; 81-4408R Lots MNEO89, MNE2A1, MNE4DK, MNE7XV, MNE8N4, MNE9M9, MNEA4T, MNEAJ8, MNEMLA, MNET9J; 81-4409L Lots MNE4W5, MNE93H, MNEEEN, MNEVOY, MNEY57, MNEY74, MNE159, MNE1H2, MNE2DK, MNEM2D, MNENLJ, MNER77, MNEV0J; 81-4411R Lot MMTVXW; 81-4413L Lot MMP0MP; 81-6404R Lot MMTR58; 81-6407L Lot MMTDN7.
Recalling Firm/
Manufacturer		 Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430-2006
For Additional Information Contact Mr. Paul Jahnke
201-831-5826
Manufacturer Reason
for Recall		 The peel strength of the inner blister may have been below internal validated requirements. The strength of the seal is directly related to long term shelf life of the sterile barrier.
FDA Determined
Cause 2		 Under Investigation by firm
Action The firm, Stryker Orthopaedics, notified their Branches/Agencies via email on 8/15/2014 and sent an "Urgent Product Recall" letter dated 8/15/2014 with a Product Recall Acknowledgement Forms to their Branches/Agencies and consignees. The letter describes the product, issue, potential hazards and actions to be taken. The consignees were instructed to complete and return the attached Product Recall Acknowledgment Form within 5 days via fax to 855-251-3635; and return the affected product to the attention of Regulatory Compliance, Stryker Orthopaedics, 325 Corporate Drive, Mahwah NJ 07430. If you have any questions, feel free to contact Sr. Regulatory Compliance Specialist to 201-831-5826.
Quantity in Commerce 1,147 in total
Distribution Worldwide Distribution: US (nationwide) including PR and countries of: Australia, Canada, China, Brazil, France, Hong Kong, India, Italy, Mexico, Netherlands, Singapore, South Africa, Sweden, and Spain.
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 = JWH and Original Applicant = HOWMEDICA OSTEONICS CORP
510(K)s with Product Code = JWH and Original Applicant = HOWMEDICA OSTEONICS CORP.
510(K)s with Product Code = JWH and Original Applicant = OSTEONICS CORP.
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