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Recall Observatory FDA recall evidence

Device 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.

Z-1634-2015

August 15, 2014

Class II

Product summary

Firm
Stryker Howmedica Osteonics Corp.
Event
Event 70994
Status
Terminated
Classification
Class II
Quantity
1,147 in total
Official record key
device-enforcement:Z-1634-2015

Official wording

Reason: 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.

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.

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.