FDA Medical Device Recalls (openFDA)
Depuy Mitek, a Johnson & Johnson Co.: DePuy Mitek Straightshot Ligament Graft Passer/Protector, 11.5 mm Catalog Number : 232220
- Recall number
- Z-0161-06
- Recalling firm
- Depuy Mitek, a Johnson & Johnson Co.
- Product
- DePuy Mitek Straightshot Ligament Graft Passer/Protector, 11.5 mm Catalog Number : 232220
- Status
- Terminated
- Initiated
- 2005-08-09
- Posted
- 2005-11-18
- Terminated
- 2006-05-02
- Reason
- Mislabeled: The kit contained the incorrect Ligament Passer. The package contained a 9.5 mm instead of the labeled 11.5mm ligament passer
- Root cause
- Other
- Action
- DePuy Mitek notified the accounts by US Mail on 8/09/05. Accounts were requested to return product.
- Quantity
- 5 boxes /10 units (50 pieces)
- Distribution
- CA, NC, VA
- Lot, serial or model codes
- Lot Number: JBV04259
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LXH
- Firm FEI
- 1221934
- Firm city
- Raynham
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28