Class II U.S. Food and Drug Administration

Howmedica Osteonics Corp. Duracon XL Angled TIB INS 11/14MM C-M064-1-300 recall: Affected devices were manufactured with Ultra High Molecular Weight

Recall published last month

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.

The hazard: Device safety concern

The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

What the notice says: 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.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-3200-2026
Published
September 23, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Howmedica Osteonics Corp.
Product type
Medical devices
Units affected
12,156 US
Distribution
Nationwide
Made in
United States
Lot / code info
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
UPC codes
07613327138191, 07613327138214, 07613327138207, 07613327138153, 07613327138283, 07613327138177, 07613327138269, 07613327138238

Products covered by this recall

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)

Check your product

The notice names 9 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 07613327138191
  • 07613327138214
  • 07613327138207
  • 07613327138153
  • 07613327138283
  • 07613327138177
  • 07613327138269
  • 07613327138238

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 156 US

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Howmedica Osteonics Corp. — The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Ask the supplier or clinic that provided it what the remedy is in your case.
  3. If you are a facility, quarantine affected stock and log the correction.
  4. Report device problems to the FDA through MedWatch.

Who pays for a device recall

The manufacturer funds the remedy. The practical question is usually which link in the chain executes it.

  • If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
  • Ask for written confirmation that the remedy was applied to your serial number. That is what an insurer or a future clinician will want to see.
  • If you bought it yourself online or from a pharmacy, go to the manufacturer’s recall page rather than the retailer; device claims are handled centrally.
  • Where the remedy is a software update, there is nothing to claim, but do confirm the version changed afterwards.

Company contact: Howmedica Osteonics Corp. — 325 Corporate Dr, Mahwah, NJ, 07430-2006

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Howmedica Osteonics Corp. medical devices recalled?

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 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…

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 07613327138191, 07613327138214, 07613327138207; lot code 156 US. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.

Where was the recalled product sold?

It was distributed nationwide.

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