Howmedica Osteonics Corp. recalls DURACON XL ANGLED TIB INS 11/14MM C-M064-1-300 SELF-PRESSURIZING GLENOID SIZE 8…
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.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Affected products & lots
- 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)C-M064-1UDI-DI 07613327138191UDI Lots130 affected lotsRX06413AC-M062-6-800RX06268AC-M062-7-500RX06275AC-M063-2-600RX06326AC-M063-5-000
+122 more
RX06350ARX06350AA5361-611107613327138191AFZT00UAFZT00ZP2N04BP3K57P3K57BP3K57FPYE43BPZA70FPZA70U5361-610507613327138214AF2S09UAF2S09ZP1H41P4T02P4T02X1P4T02X2P4T02X3P4T02X4P4T02X5P4T02X65361-610707613327138207AF3E00AF3E00BAF3E00FAF3E00GAF3E00QAF3E00SP4A238P4A238X1P4A238X2P4A238X3P4A238X4P4A238X5P4A238X6P4A238X7P4A238X8P4L09P4L09X1P4L09X10P4L09X2P4L09X3P4L09X4P4L09X5P4L09X6P4L09X7P4L09X8P4L09X9P4N06P4N06X1P4N06X2P4N06X3P4N06X4P4N06X5P4N06X6P4N06X7P4T03P4T03X1P4T03X2P4T03X3P4T03X4P4T03X5P4T03X6P4T03X7P4T03X8P4V01P4V01X1P4V01X2P4V01X3P4V01X4P4V01X5P4V01X6P4V01X7P4V01X85361-610907613327138153AF3E02IAF3E02SAF3E02ZP1H39Q5361-621107613327138283AFZS09FAFZS09GAFZS09SP2N08PYC30X1PYW24X1PZKDHX15361-6205076133271381771NMMPE1NNMPEP3K58P3K58BP3K58F5361-620707613327138269AF2S10BAF2S10FAF2S10GP4A241P4A241X1P4A241X2P4A241X3P4V03P4V03X1P4V03X2P4V03X3P4V03X4P4V03X5PZKDFX15361-620907613327138238AF2K03ZAFZS10SAFZS10U
What the firm is doing
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.
DistributionShow detailsHide
Worldwide distribution - US Nationwide and the countries of Canada, LATAM, Europe, Asia Pacific, and South Africa.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-3200-2026
- FDA 510(k) clearance · K962082The device's official FDA premarket clearance record
- FDA device classification · KWSOfficial FDA classification for this device type
- CFR regulation · 21 CFR 888.3660The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Howmedica Osteonics Corp.Search for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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