Z-0486-2022 Class II Terminated
FDA device recall Z-0486-2022 was initiated by DePuy Orthopaedics, Inc. on December 7, 2021 and is designated Class II. Reason for recall: Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage The recall status is terminated (terminated May 17, 2024). Affected quantity: 781 units.
Recall Details
- Product Type
- Devices
- Report Date
- January 19, 2022
- Initiation Date
- December 7, 2021
- Termination Date
- May 17, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 781 units
Product Description
GLOBAL UNITE STD STEM SZ 10 Part Number: 110010100
Reason for Recall
Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Austria, Australia, Belgium, Canada, Denmark, Estonia, Finland, France, Germany, Greece, Ireland, Israel, Italy, Netherlands, New Zealand, Norway, Poland, South Africa, Sweden, Switzerland, Thailand, United Kingdom.
Code Information
Lot #: 9793653, 9802160, 9802161, 9802162, 9802163, 9802164, 9802165, 9802166, 9802167, 9802168, 9802169, 9802170, 9802171, 9802172, 9802173, 9802174, 9802175, 9802176, 9802177, 9802178, 9802179, 9802180, 9802181, 9802182, 9802183, 9802184, 9802185, 9802186, 9802187, 9802188, 9802189, 9802190, 9802191, 9818345, 9824373, 9824374, 9824375, 9824376, 9824377, 9824378, 9824379, 9824380, 9824381, 9824382, 9824383, 9824384, 9824385, 9824386, 9824387, 9824388, 9824389, 9824390, 9824391, 9824392, 9824393, 9824394, 9824395, 9824398, 9824399, 9824400, 9824401, 9824402, 9824403, 9832827, 9841211, 9841212, 9842708, 9842709, 9842710, 9842711, 9843084, 9851725, 9851727, 9851728, 9851729, 9851730, 9851731, 9851732, 9851733, 9851734, 9851736, 9851739, 9851742, 9851743, 9851744, 9864146, 9874719, 9874720, 9874721, 9874722, 9874724, 9874726, 9874727, 9874728, 9874729, 9874733, 9874739, 9874744 GTIN: 10603295004080