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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Implants & Prosthetics

Howmedica Osteonics Corp.: Knee Replacement Implants Recalled Due to Material Oxidation and Failure Risk

Agency Publication Date: January 31, 2024
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Summary

Howmedica Osteonics (Stryker) is recalling 1,625 units of various knee replacement components, including Scorpio and Duracon brand patellas and tibial inserts. These orthopedic implants were manufactured using plastic raw material (UHMWPE) that was over five years old, which can lead to high levels of oxidation. This oxidation may cause the material to degrade or fail prematurely, potentially requiring additional medical intervention. These devices were distributed across the United States and multiple international locations.

Risk

The oxidation of the plastic material within these knee inserts can negatively impact their material properties, potentially leading to mechanical failure or advanced wear within the body. While no specific injuries are listed in this report, such material degradation often results in the need for complex revision surgeries to replace the failing components.

What You Should Do

  1. Identify if your implant is affected by checking your surgical records or contacting your orthopedic surgeon's office for the part numbers and lot numbers listed in this recall.
  2. Specific products include various SCORPIO RECESSED PATELLA models (Part numbers 3044-0026, 3044-0028, 3044-0030, 3044-0032), SCORPIO TS TIB INSERTS (72-4 series), and DURACON models like the PRIMARY REV.TIB.INSERT (6637-4-031).
  3. If you have one of the affected lot numbers, such as SCORPIO PATELLA Lot PVDY or SERIES II TIBIAL INSERT Lot WK4PX0, contact your healthcare provider immediately to discuss any symptoms or the need for monitoring.
  4. Patients who have already received these implants should follow their surgeon's recommended follow-up schedule and report any new pain, swelling, or instability in the knee.
  5. Healthcare facilities should check their inventory for any unused affected products, quarantine them immediately, and contact the manufacturer for return instructions.
  6. For further information or questions regarding this recall, contact Howmedica Osteonics Corp. (Stryker) at their Mahwah, New Jersey headquarters or contact the FDA at 1-888-463-6332.

Your Remedy Options

๐Ÿ“‹Other Action

Contact healthcare provider or manufacturer

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: SCORPIO RECESSED PATELLA (3044-0026)
Model / REF:
3044-0026
UPC Codes:
07613327033779
Lot Numbers:
PVDY
TEN1
AMN1
V644
MHHE
4T1K
V355
55LK
JR6R
Product: SCORPIO RECESSED PATELLA (3044-0028)
Model / REF:
3044-0028
UPC Codes:
07613327033793
Lot Numbers:
A59N
EP7J
X79L
Product: SCORPIO RECESSED PATELLA (3044-0030)
Model / REF:
3044-0030
UPC Codes:
07613327033809
Lot Numbers:
PD99
6AHH
RY3J
Product: SCORPIO RECESSED PATELLA (3044-0032)
Model / REF:
3044-0032
UPC Codes:
07613327033823
Lot Numbers:
6LR4
R14V
N882
Product: SERIES II TIBIAL BEAR INSERT (3052-0515)
Model / REF:
3052-0515
UPC Codes:
07613327034042
Lot Numbers:
WK4PX0
Product: SERIES II TIBIAL BEAR INSERT (3052-0524)
Model / REF:
3052-0524
UPC Codes:
07613327034073
Lot Numbers:
K349TP
Product: SCORPIO TS TIB INSERT (72-4-0321)
Model / REF:
72-4-0321
UPC Codes:
07613327034349
Lot Numbers:
TA21X9
Product: SCORPIO TS TIB INSERT (72-4-0510)
Model / REF:
72-4-0510
UPC Codes:
07613327034363
Lot Numbers:
H43RDK
WR1RE3
768NEY
4J13P1
Product: SCORPIO TS TIB INSERT (72-4-7512)
Model / REF:
72-4-7512
UPC Codes:
07613327034790
Lot Numbers:
5M6LM1
Product: SCORPIO TS TIB INSERT (72-4-7514)
Model / REF:
72-4-7514
UPC Codes:
07613327034820
Lot Numbers:
482LM8
HH43K7
Product: SCORPIO TS TIB INSERT (72-4-7516)
Model / REF:
72-4-7516
UPC Codes:
07613327034806
Lot Numbers:
TN1746
KK82WY
Product: SCORPIO TS TIB INSERT (72-4-7518)
Model / REF:
72-4-7518
UPC Codes:
07613327034813
Lot Numbers:
9P8360
AK8393
Product: SCORPIO TS TIB INSERT (72-4-7521)
Model / REF:
72-4-7521
UPC Codes:
07613327034837
Lot Numbers:
VA0X4T
Product: SCORPIO TS TIB INSERT (72-4-7524)
Model / REF:
72-4-7524
UPC Codes:
07613327034844
Lot Numbers:
V68WW1
93400601
Product: Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy (72-15-0324)
Model / REF:
72-15-0324
UPC Codes:
07613154020133
Lot Numbers:
53867101
Product: Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy (72-16-0908)
Model / REF:
72-16-0908
UPC Codes:
07613154020638
Lot Numbers:
42968601
Product: Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy (72-16-0910)
Model / REF:
72-16-0910
UPC Codes:
07613154020645
Lot Numbers:
43103101
Product: SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #11
Model / REF:
73-0110
UPC Codes:
07613327050288
Lot Numbers:
79E0
274P
WEKJ
LH82
33ND
Product: SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #5
Model / REF:
73-0510
UPC Codes:
07613327050301
Lot Numbers:
57A2
3WP6
E10K
X49N
WJ3L
38TY
Product: SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #7
Model / REF:
73-0710
UPC Codes:
07613327050295
Lot Numbers:
RLAR
2P84
EW6V
90AV
4JHN
65A3
22MP
NNE7
Y373
58LA
VXAL
4201
A2AN
5YP8
X0P9
9A8T
6LN7
WEL3
NDK3
25WJ
T2JW
YVWT
7DR0
DMVL
Product: SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #9
Model / REF:
73-0910
UPC Codes:
07613327050332
Lot Numbers:
X1WP
6KE9
DL4V
HHPW
1NL2
4JHW
0TNX
WN5E
2EM2
96N0
HW7E
T9NM
J72T
M73H
HM8H
MEM7
M8HN
WL3Y
Product: SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #11
Model / REF:
73-2110
UPC Codes:
07613327033816
Lot Numbers:
LT28
4TXX
Product: SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #7
Model / REF:
73-2710
UPC Codes:
07613327033847
Lot Numbers:
V25H
MD9E
5MYL
H9T8
845P
Product: SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #9
Model / REF:
73-2910
UPC Codes:
07613327033854
Lot Numbers:
A02W
NPPV
75TX
6RLN
Product: SCORPIO U-DOME PATELLA (73-3110)
Model / REF:
73-3110
UPC Codes:
07613327033861
Lot Numbers:
XEA7
8P83
690Y
MRM3
67D4
4902
YNP7
3AYN
AYHM
W3MD
76KN
K4P9
792H
43T8
MW40
Product: SCORPIO U-DOME PATELLA (73-3308)
Model / REF:
73-3308
UPC Codes:
07613327033878
Lot Numbers:
2H58
2J0W
8H52
64MJ
X0H9
70E9
Product: SCORPIO U-DOME PATELLA (73-3508)
Model / REF:
73-3508
UPC Codes:
07613327033885
Lot Numbers:
EPXH
DYAE
XVK2
PVP9
LJ0K
12R3
N8P6
T355
8HDN
A3EV
5LKW
R04Y
RKT1
D06K
01JR
3PA4
0AYL
W424
53T1
Y7X2
Product: SCORPIO U-DOME PATELLA (73-3708)
Model / REF:
73-3708
UPC Codes:
07613327033892
Lot Numbers:
RDWN
4W3T
V768
VJ05
TWT6
ADK0
855
D6D9
TXL1
53RN
KR24
M3T4
VE90
EKK2
36L1
NH6E
8PWK
R9A4
NWXA
D47L
5JVL
D16P
E2LP
927H
JR5N
Product: SCORPIO U-DOME PATELLA (73-3710)
Model / REF:
73-3710
UPC Codes:
07613327033908
Lot Numbers:
RNT5
3YNP
PEA1
NNA5
5A2R
98AH
T1JH
8D72
E0VH
3PA0
05L4
R608
Product: SCORPIO U-DOME PATELLA (73-3910)
Model / REF:
73-3910
UPC Codes:
07613327033915
Lot Numbers:
73JP
V17W
N2MY
PK0D
D3M3
LEAY
4NTR
R5WA
JN8M
084W
K6YE
84A4
XREK
YNM1
LY5M
M1AT
4873
Product: Scorpio NRG Tibial Brg Insert Assy (82-2-0908)
Model / REF:
82-2-0908
UPC Codes:
04546540400734
Lot Numbers:
42874701
42912101
42995601
Product: Scorpio NRG Tibial Brg Insert Assy (82-2-0910)
Model / REF:
82-2-0910
UPC Codes:
04546540400741
Lot Numbers:
42912201
42961901
Product: TRIDENT 0 deg POLY INSERT (620-00-28J)
Model / REF:
620-00-28J
Lot Numbers:
38059601
Product: TRIDENT 0 deg POLY INSERT (620-00-32J)
Model / REF:
620-00-32J
Lot Numbers:
29518001
Product: P7 28MM 10 DEGREE +4MM INSERT
Model / REF:
6302-6-107
UPC Codes:
07613153076155
Lot Numbers:
61311701
62122001
Product: P7 32MM 1O DEGREE +4MM INSERT
Model / REF:
6302-6-307
UPC Codes:
07613153076407
Lot Numbers:
62112001
62120801
Product: LEFT SMALL-PCA MOD.REV.DUR.REV.INSERT
Model / REF:
6637-0-028
UPC Codes:
04546540305831
Lot Numbers:
42771401
Product: LEFT LARGE-PCA MOD.REV.DUR.REV.INSERT (6637-0-228)
Model / REF:
6637-0-228
UPC Codes:
04546540306012
Lot Numbers:
54537601
Product: LEFT LARGE-PCA MOD.REV.DUR.REV.INSERT (6637-0-231)
Model / REF:
6637-0-231
UPC Codes:
04546540306029
Lot Numbers:
42787901
Product: LEFT X-LARGE-PCA MOD.REV.DUR.REV.INSERT
Model / REF:
6637-0-328
UPC Codes:
04546540306104
Lot Numbers:
42579701
Product: PRIMARY REV.TIB.INSERT-DURACON
Model / REF:
6637-4-031
UPC Codes:
04546540306920
Lot Numbers:
36273601
36609701
Product: PS LIPPED TIBIAL INSERT ASSY DURACON (6742-1-411)
Model / REF:
6742-1-411
UPC Codes:
04546540324108
Lot Numbers:
584223
Product: TIBIAL BEARING INSERT SERIES P-S I ASSY
Model / REF:
7291-0324
UPC Codes:
04546540117144
Lot Numbers:
59065701

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93687
Status: Active
Manufacturer: Howmedica Osteonics Corp.
Sold By: Hospitals; Surgical Centers; Orthopedic Clinics
Manufactured In: United States
Units Affected: 21 products (94 units US; 131 units OUS; 52 units US; 20 units OUS; 77 units US; 2 units OUS; 70 units US; 5 units US; 5 units US; 9 units US; 61 units US; 46 units OUS; 76 units US;; 269 units US; 307 units OUS; 192 units US; 4 units; 36 units US; 16 units US; 56 units OUS; 107 units US; 176 units OUS; 1 units US; 146 units oUS; 137 units US; 326 units OUS; 149 units US; 424 units OUS; 118 units US; 212 units OUS; 143 units US; 290 units OUS; 4 units US)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.