FDA Device recall Z-2217-2012
DePuy Custom Implant Devices Packaging: Packaging was not standardized on customs, it was dependant on the geometry of the product Product…
- FDA Device
- Class II
- terminated
- Published 2012-08-22
On 2012-08-22 the FDA classified a Class II recall of DePuy Custom Implant Devices Packaging: Packaging was not standardized on customs, it was dependant on the geometry of the product Product… by Depuy Orthopaedics, citing in connection with a Warning Letter received from the U.S. Food & Drug Administration on December 9, 2011, DePuy Orthopaedics is taking steps to retrieve custom device implants th….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2217-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-07-31 |
| Published | 2012-08-22 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Depuy Orthopaedics |
| Distribution | US |
Product
DePuy Custom Implant Devices Packaging: Packaging was not standardized on customs, it was dependant on the geometry of the product Product Usage: Description: Devices meeting the regulatory definition of a custom medical device are those which are provided by prescription at a physician s request to meet a specific patient need and have been exempt from FDA premarket review under the Federal Food, Drug, and Cosmetic Act since 1976. Intended Use: See information contained in the Information for Use for Custom Implant Device (IFU-0902-00-500 rev C)
Reason
In connection with a Warning Letter received from the U.S. Food & Drug Administration on December 9, 2011, DePuy Orthopaedics is taking steps to retrieve custom device implants that surgeons may have ordered from DePuy Orthopaedics, but not implanted. DePuy Orthopaedics received a Warning Letter from the FDA on December 9, 2011 regarding custom device implants. DePuy Orthopaedics has discontinue
Identifiers
| code_info | Part Number: 101178997, 101201997, 101201998, 101201999, 101201999, 101214999, 101402998, 101402999, 101403999, 1014369…Part Number: 101178997, 101201997, 101201998, 101201999, 101201999, 101214999, 101402998, 101402999, 101403999, 101436996, 101436997, 101466996, 101466997, 101466997, 101466997, 101466997, 101467996, 101467997, 101467997, 101467997, 101467997, 101467998, 101468997, 101468997, 101468997, 101468997, 101468999, 101469996, 101469997, 101469997, 101469997, 101469997, 101469997, 101470996, 101470997, 101470997, 101470997, 101470997, 101470999, 101471997, 101471997, 101471997, 101471997, 101471997, 101472990, 101472991, 101472992, 101472993, 101480961, 101480962, 101480963, 101480964, 101480977, 101480978, 101480983, 101480984, 101480985, 101480988, 101480989, 101480992, 101480993, 101480998, 101480999, 101580988, 101580989, 101580990, 101580991, 101580992, 101580993, 101580994, 101580995, 101811936, 101811936, 101811992, 101811994, 101811996, 101812935, 101812936, 101812993, 101812994, 101812995, 101812996, 101812998, 101813936, 101813936, 101813985, 101813988, 101813989, 101813990, 10181399 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2217-2012%22
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