Class 2 Device Recall Stryker

• Date Initiated by Firm: July 30, 2026
• Date Posted: September 16, 2026
• Recall Status: Open, Classified
• Recall Number: Z-3200-2026
• Recall Event ID: 99558
• 510(K)Number: K962082
• Product Classification: Prosthesis, shoulder, semi-constrained, metal/polymer cemented - Product Code KWS
• 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)
• Code Information: 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 P4V03X4 P4V03X5 PZKDFX1 5361-6209 UDI-DI 07613327138238 Lots AF2K03Z AFZS10S AFZS10U
• FEI Number: 3003070421
• Recalling Firm/ Manufacturer: Howmedica Osteonics Corp.; 325 Corporate Dr; Mahwah NJ 07430-2006
• For Additional Information Contact: Evelyn Ryan; 201-831-5000
• Manufacturer 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: 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.
• Quantity in Commerce: 12,156 US
• Distribution: Worldwide distribution - US Nationwide and the countries of Canada, LATAM, Europe, Asia Pacific, and South Africa.
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = KWS