Fixion PF (''Proximal Femur'') Hip Peg. Fixion PF Hip Pegs are manufactured in the following various lengths; 80mm, 81mm
FDA device recall Z-0943-03 · posted 2003-06-21 · Terminated
Recall details
- Recalling firm
- Disc Orthopaedic Technologies Inc
- Reason for recall
- The Fixion Interlocking Proximal Femoral Hip Pegs are defective due to possible tension failure.
- Action taken
- The first letter, dated Monday October 14, 2002, went out to 10 of the firm''s agents who directly handled this line of product. The firm then sent out a follow-up letter, dated Wednesday December 11, 2002, to the same agents that they had previously made contact with to assure their knowledge regarding the recall.
- Root cause
- Other
- Status
- Terminated
- Product code
- NDH
- Quantity affected
- 1540
- Distribution
- Product is manufactured at Disc-O-Tech Medical Technologies Ltd. located at 3 Hasadnaot St., Herzliya 46728, Israel. Product is then distributed to the rest of the world including the U.S.A. Products
- Date initiated
- 2002-12-11
- Date posted
- 2003-06-21
- Date terminated
- 2003-04-08
- Location
- Cranbury, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAILING SYSTEM) (K021324) | Disco-O-Tech Medical Technologies, Ltd. | 2002-05-23 |
| MODIFICATION TO FIXION INTERLOCKING PROXIMAL FEMORAL INTRAMEDULLARY NAILING SYSTEM (K012967) | Disco-O-Tech Medical Technologies, Ltd. | 2001-10-04 |
| FIXION INTERLOCKING PROXIMAL FEMORAL NAILING SYSTEM (K010988) | Disc-O-Tech Medical Technologies, Ltd. | 2001-06-19 |