DePuy Custom Implant Devices Packaging: Packaging was not… — Class II medical device recall Z-2217-2012
Terminated recall by DePuy Orthopaedics, Inc., reported 2012-08-22, distributed nationwide. In connection with a Warning Letter received from the U.S. Food & Drug Administration on December 9, 2011, DeP
| Recall number | Z-2217-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | DePuy Orthopaedics, Inc., Warsaw, IN, United States |
| Recall initiated | 2012-07-31 |
| Classified | 2012-08-16 |
| Reported by FDA | 2012-08-22 |
| Terminated | 2014-01-13 |
| Distributed | Nationwide (US) |
| Quantity | 8,338 |
| Lot numbers | 101933, 102840, 103293, 103312, 104418, 104419, 104422, 104475, 104583, 104698, 105099, 105378, 105512, 105913, 105936, 106754, 107680, 107682, 108010, 108211, 108215, 108430, 108759, 108761, 108762, 109192, 109202, 109241, 109261, 109264, 109265, 109487, 109607, 109620, 110919, 110923, 111176, 111183, 111197, 111473 and 460 more |
| Model numbers | 101178997, 101201997, 101201998, 101201999, 101214999, 101402998, 101402999, 101403999, 101436996, 101436997, 101466996, 101466997, 101467996, 101467997, 101467998, 101468997, 101468999, 101469996, 101469997, 101470996, 101470997, 101470999, 101471997, 101472990, 101472991 and 475 more |
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 for recall
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
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.