PROFEMUR PLUS CoCr MODULAR NECK, REF: PHAC1254, SIZE LONG, ORIENTATION 8 degree VAR/VAL. 12/14 SLT Taper. Orthopedic hip
FDA device recall Z-2743-2015 · posted 2015-09-28 · Terminated
Recall details
- Recalling firm
- MicroPort Orthopedics, Inc.
- Reason for recall
- Unexpected rate of postoperative fractures resulting in the need for revision surgery.
- Action taken
- Micro Port Orthopedics sent a Voluntary Device Product Recall letter dated August 7, 2015, via Fed Ex to all affected customers. The letter identified the product, the problem, and action to be taken by the customer. Customers were instructed to locate and return effected product immediately. Customers with questions were instructed to call 1-866-872-0211. Customers were also asked to return the enclosed form immediately even if they do not have any affected product to return.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- MBL
- Quantity affected
- 10,489 units
- Distribution
- Worldwide Distribution - US (nationwide) and Internationally to AT, BE, CA, CN, CZ, DE, ES, FI, FR, GB, IT, KR, LT, LV, NL, NO, PE, PL, PT, RU, and ST.
- Date initiated
- 2015-08-04
- Date posted
- 2015-09-28
- Date terminated
- 2018-08-17
- Location
- Arlington, TN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PROFEMUR HIP SYSTEM MODULAR NECKS (K100866) | Wrightmedicaltechnologyinc | 2010-04-28 |
| PROFEMUR HIP SYSTEM MODULAR NECKS (K091423) | Wrightmedicaltechnologyinc | 2009-08-25 |