Conformis iTotal Hip Replacement System: HBS-033-00xx-020101, (HIP-PATIENT SPECIFIC STEM RIGHT)
Class I - DangerousWhat Should You Do?
- Check if you have this product: HBS-033-0010-020101: Serial Numbers: 425365, 425428, 425767, 425954, 426249, 426408, 426508, 426722, 426725, 428146, 428328, 429186, 429310, 429857, 430590, 431869, 432271, 432292, 432555, 432773, 433524, 434063, 436063, 436522, 438792, 439464, 439559, 441029; HBS-033-0011-020101: Serial Numbers: 423937, 424879, 425273, 425425, 425457, 425605, 425627, 426730, 427699, 427760, 427897, 428066, 428791, 428802, 429699, 429829, 429856, 429940, 430691, 431029, 432687, 434510, 435069, 435409, 435886, 435961, 436017, 436659, 437864, 437866, 438568, 439309, 439457, 439650, 441929; HBS-033-0012-020101: Serial Numbers:424288, 424377, 426081, 426298, 426581, 426608, 426873, 427353, 427759, 428504, 428744, 428814, 428940, 429787, 429854, 429928, 430045, 430344, 430780, 431025, 431032, 431443, 431813, 432098, 432925, 434265, 434704, 435120, 435483, 435790, 436682, 436891, 437036, 437050, 438471, 438511, 438570, 439453, 439471, 439738, 441009, 441527, 442347; HBS-033-0013-020101: Serial Numbers: 423539, 425277, 426121, 430033, 430129, 430461, 432012, 434291, 435938, 436951, 437614, 437654, 437776, 437932, 438157, 438304, 438384, 439822, 440273, 440446, 441053, 441714, 442149; HBS-033-0014-020101: Serial Numbers: 423852, 425345, 425968, 426897, 427830, 428294, 428697, 428836, 429416, 430028, 431541, 432156, 432399, 432421, 432440, 432524, 433245, 434239, 434884, 435146, 435366, 437208, 438079, 438485, 438916, 438991, 439849, 440604, 440673, 441492; HBS-033-0015-020101: Serial Numbers: 426179, 429192, 429828, 429855, 431489, 431512, 432017, 433642, 436330, 437089, 437495, 437651, 437714, 437906, 438105, 438296, 438739, 438784, 440265; HBS-033-0016-020101: Serial Numbers: 426119, 435562, 437516, 438708, 440704
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Conformis, Inc.
- Reason for Recall:
- Discrepancy of 3mm between the values displayed and approved by surgeons in iViews as the neck/head lengths and the resulting neck/head lengths in the manufactured implants.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Conformis iTotal Hip Replacement System: HBS-033-00xx-020101, (HIP-PATIENT SPECIFIC STEM RIGHT)
Product Codes/Lot Numbers:
HBS-033-0010-020101: Serial Numbers: 425365, 425428, 425767, 425954, 426249, 426408, 426508, 426722, 426725, 428146, 428328, 429186, 429310, 429857, 430590, 431869, 432271, 432292, 432555, 432773, 433524, 434063, 436063, 436522, 438792, 439464, 439559, 441029; HBS-033-0011-020101: Serial Numbers: 423937, 424879, 425273, 425425, 425457, 425605, 425627, 426730, 427699, 427760, 427897, 428066, 428791, 428802, 429699, 429829, 429856, 429940, 430691, 431029, 432687, 434510, 435069, 435409, 435886, 435961, 436017, 436659, 437864, 437866, 438568, 439309, 439457, 439650, 441929; HBS-033-0012-020101: Serial Numbers:424288, 424377, 426081, 426298, 426581, 426608, 426873, 427353, 427759, 428504, 428744, 428814, 428940, 429787, 429854, 429928, 430045, 430344, 430780, 431025, 431032, 431443, 431813, 432098, 432925, 434265, 434704, 435120, 435483, 435790, 436682, 436891, 437036, 437050, 438471, 438511, 438570, 439453, 439471, 439738, 441009, 441527, 442347; HBS-033-0013-020101: Serial Numbers: 423539, 425277, 426121, 430033, 430129, 430461, 432012, 434291, 435938, 436951, 437614, 437654, 437776, 437932, 438157, 438304, 438384, 439822, 440273, 440446, 441053, 441714, 442149; HBS-033-0014-020101: Serial Numbers: 423852, 425345, 425968, 426897, 427830, 428294, 428697, 428836, 429416, 430028, 431541, 432156, 432399, 432421, 432440, 432524, 433245, 434239, 434884, 435146, 435366, 437208, 438079, 438485, 438916, 438991, 439849, 440604, 440673, 441492; HBS-033-0015-020101: Serial Numbers: 426179, 429192, 429828, 429855, 431489, 431512, 432017, 433642, 436330, 437089, 437495, 437651, 437714, 437906, 438105, 438296, 438739, 438784, 440265; HBS-033-0016-020101: Serial Numbers: 426119, 435562, 437516, 438708, 440704
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1776-2019
Related Recalls
The hip cup liner that was packaged with the incorrect labeling. HDL-060-C22S-000101 from Lot 1788258 contained a hooded liner, but it was labeled to have a standard liner.
Size 5 Tibial Tray from Lot 508287 was packaged in a Size 4 box from Lot 540287. It was confirmed that Lot 540287 and Lot 508287 were swapped between the pouching and final pack.
30mm screws were labeled as 25mm screws.