Recall Z-3200-2026

Howmedica Osteonics Corp. · initiated July 30, 2026

Open, Classified

Product

DURACON XL ANGLED TIB INS 11/14MM C-M064-1-300 SELF-PRESSURIZING GLENOID SIZE 8 C-M062-6-800 C-M062-7-500 C-M063-2-600 SELF-PRESSURIZING GLENOID SIZE 9 C-M063-5-000 SHOULDER - GLENOID #11 5361-6111 SHOULDER - GLENOID #5 5361-6105 SHOULDER - GLENOID #7 5361-6107 SHOULDER - GLENOID #9 5361-6109 SHOULDER - KEELED GLENOID #11 5361-6211 SHOULDER - KEELED GLENOID #5 5361-6205 SHOULDER - KEELED GLENOID #7 5361-6207 SHOULDER - KEELED GLENOID #9 5361-6209 Orthopaedic implant components manufactured from UHMWPE (polyethylene)

Codes / lots: C-M064-1-300 No UDI Lot RX06413A C-M062-6-800 No UDI Lot RX06268A C-M062-7-500 No UDI Lot RX06275A C-M063-2-600 No UDI Lot RX06326A C-M063-5-000 No UDI Lots RX06350A RX06350AA 5361-6111 UDI-DI 07613327138191 Lots AFZT00U AFZT00Z P2N04B P3K57 P3K57B P3K57F PYE43B PZA70F PZA70U 5361-6105 UDI-DI 07613327138214 Lots AF2S09U AF2S09Z P1H41 P4T02 P4T02X1 P4T02X2 P4T02X3 P4T02X4 P4T02X5 P4T02X6 5361-6107 UDI-DI 07613327138207 Lots AF3E00 AF3E00B AF3E00F AF3E00G AF3E00Q AF3E00S P4A238 P4A238X1 P4A238X2 P4A238X3 P4A238X4 P4A238X5 P4A238X6 P4A238X7 P4A238X8 P4L09 P4L09X1 P4L09X10 P4L09X2 P4L09X3 P4L09X4 P4L09X5 P4L09X6 P4L09X7 P4L09X8 P4L09X9 P4N06 P4N06X1 P4N06X2 P4N06X3 P4N06X4 P4N06X5 P4N06X6 P4N06X7 P4T03 P4T03X1 P4T03X2 P4T03X3 P4T03X4 P4T03X5 P4T03X6 P4T03X7 P4T03X8 P4V01 P4V01X1 P4V01X2 P4V01X3 P4V01X4 P4V01X5 P4V01X6 P4V01X7 P4V01X8 5361-6109 UDI-DI 07613327138153 Lots AF3E02I AF3E02S AF3E02Z P1H39Q 5361-6211 UDI-DI 07613327138283 Lots AFZS09F AFZS09G AFZS09S P2N08 PYC30X1 PYW24X1 PZKDHX1 5361-6205 UDI-DI 07613327138177 Lots 1NMMPE 1NNMPE P3K58 P3K58B P3K58F 5361-6207 UDI-DI 07613327138269 Lots AF2S10B AF2S10F AF2S10G P4A241 P4A241X1 P4A241X2 P4A241X3 P4V03 P4V03X1 P4V03X2 P4V03X3…

Reason for recall

Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and inflammation.

FDA-determined cause: Process change control

Action taken

Firm began notifying customers on July 30, 2026, via FedEx 2-day air. Customers were instructed to quarantine and discontinue use of the affected product. Affected product should be returned to the firm.

Details

Recall number
Z-3200-2026
Initiated
July 30, 2026
Posted by FDA
September 16, 2026
Product code
KWS – Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Quantity
12,156 US
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, LATAM, Europe, Asia Pacific, and South Africa.
Recalling firm
Howmedica Osteonics Corp., Mahwah, NJ

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-3195-2026 AXLE PIN ASSY LARGE ELBOW COBALT CHROME Catalog No. C-M112-2-500 Orthopaedic implant…Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged… 07/30/2026Open, Classified
Z-3196-2026 OMNIFIT SERIES I ACET. INSERT 10 22mm ID Catalog No. 2001-2246 Orthopaedic implant…Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged… 07/30/2026Open, Classified
Z-3197-2026 ALL POLY CONSTRAINED INSERT 54MM 69-2854 NRG KNEE CR 82-2-0512 82-2-0518 82-2-0912 NRG…Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged… 07/30/2026Open, Classified
Z-3198-2026 TRIATHLON HINGE INSERT SIZE 4 11MM 5612-P-411 TRIATHLON HINGE INSERT SIZE 4 13MM…Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged… 07/30/2026Open, Classified
Z-3199-2026 ABG I ACETABULAR INSERT HOODED 28mm ID X 48mm C-M079-2-801 ARC2F ACETABULAR INSERT…Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged… 07/30/2026Open, Classified
Z-3201-2026 ACETABULAR CUP UHMWPE 61-3258 ALL POLY CONSTRAINED INSERT 44MM 69-2244 ALL POLY…Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged… 07/30/2026Open, Classified
Z-3202-2026 BEARING AND AXLE BUSHING ASSY STD ELBOW C-M113-1-301 KRH REV TIB INS 16mm THK .640 DIA…Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged… 07/30/2026Open, Classified
Z-3203-2026 SCORPIO RECESSED METAL BACKED PATELLA 3045-0026 3045-0028 3045-0030 3045-0032…Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged… 07/30/2026Open, Classified
Z-3204-2026 TRIDENT 0 POLY INSERT 28mm ID 620-00-28D Orthopaedic implant components manufactured…Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged… 07/30/2026Open, Classified
Z-3205-2026 SCORPIO + MOBILE BEARING PCS 78-5-0910 SYSTEM ONE BIPOLAR 40MM 6074-4022 SYSTEM ONE…Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged… 07/30/2026Open, Classified
Z-3206-2026 SCORPIO C-DOME PATELLA 73-2710 73-2910 SCORPIO U-DOME PATELLA 73-3110 73-3508 73-3708…Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged… 07/30/2026Open, Classified