Recall Z-1888-2014
The Anspach Effort, Inc. · initiated November 28, 2012
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
ANSPACH***REF 98-0019***Modified MDA Tube with MA-D20 Attachment***Rx Only*** This device is intended to be used with Anspach Systems
Codes / lots: Part Number: 98-0019; Serial Number: 200422
Reason for recall
The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.
FDA-determined cause: Process design
Action taken
The Anspach Effort, Inc. sent an Urgent Medical Device Recall letter dated December 21, 2012 to all affected customers. The letter identified the affected products, problems and actions to be taken. Customers were instructed to remove and return the affected products and complete the attached reply form and return to The Anspach Effort Inc. For questions contact Anspach Product Support at (800) 327-6887. For questions regarding this recall call 561-494-3706.
Details
- Recall number
- Z-1888-2014
- Initiated
- November 28, 2012
- Posted by FDA
- June 25, 2014
- Terminated
- August 7, 2014
- Product code
- HBE – Drills, Burrs, Trephines & Accessories (Simple, Powered)
- Quantity
- 1
- Distribution
- Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .
- Recalling firm
- The Anspach Effort, Inc., Palm Beach Gardens, FL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1875-2014 Class II | ANSPACH***Knotless Suture Anchor Deployment Tool, Custom***Rx Only*** This device is…The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling the Anspach Custom Devices. The units and… | 11/28/2012Terminated |
| Z-1876-2014 Class II | ANSPACH***REF 98-0020***Modified Arthroscopic Knotless Suture Anchor Deployment Tool…The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were… | 11/28/2012Terminated |
| Z-1877-2014 Class II | ANSPACH***REF 98-0022***8 mm Coarse Headless Screw with Driver***Rx Only*** This device…The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were… | 11/28/2012Terminated |
| Z-1878-2014 Class II | ANSPACH***REF 98-0029***8 mm Coarse Threaded Headless Bone Screw***Rx Only*** This…The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were… | 11/28/2012Terminated |
| Z-1879-2014 Class II | ANSPACH***Custom MCA5-1SD with Extended Exposure***Rx Only*** This device is intended to…The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were… | 11/28/2012Terminated |
| Z-1880-2014 Class II | ANSPACH***REF 98-0001***eMax Hand Control***Rx Only*** This device is intended to be…The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were… | 11/28/2012Terminated |
| Z-1881-2014 Class II | ANSPACH***eMax2 Lower Profile Foot Pedal***Rx Only*** This device is intended to be used…The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were… | 11/28/2012Terminated |
| Z-1882-2014 Class II | ANSPACH***REF 98-0003***Sagittal microSaw Attachment Custom***Rx Only*** This device is…The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were… | 11/28/2012Terminated |
| Z-1883-2014 Class II | ANSPACH***MA Attachment, Straight version Custom***Rx Only*** This device is intended to…The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were… | 11/28/2012Terminated |
| Z-1884-2014 Class II | ANSPACH***REF 98-0008***7cm Medium Attachment Custom***Rx Only*** This device is…The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were… | 11/28/2012Terminated |
| Z-1885-2014 Class II | ANSPACH***REF 98-0010***2.37mm Spiral Drill, for Short Attachment (Non-Sterile)***Rx…The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were… | 11/28/2012Terminated |
| Z-1886-2014 Class II | ANSPACH***Modified QD11 Attachment with Soft Tissue Protector***Rx Only*** This device…The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were… | 11/28/2012Terminated |
| Z-1887-2014 Class II | ANSPACH***REF 98-0016***eMax 2 Modified Hand Control***Rx Only*** This device is…The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were… | 11/28/2012Terminated |
| Z-1889-2014 Class II | ANSPACH***REF 98-0021***eMax2 Console with Irrigation***Rx Only*** This device is…The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were… | 11/28/2012Terminated |
| Z-1890-2014 Class II | ANSPACH***REF 98-0023***Custom 5 cm Extension Bearing Sleeve***Rx Only*** This device is…The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were… | 11/28/2012Terminated |
| Z-1891-2014 Class II | ANSPACH***REF 98-0024***Nose Cone Cover***Rx Only*** This device is intended to be used…The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were… | 11/28/2012Terminated |
| Z-1892-2014 Class II | ANSPACH***REF 98-0025***Custom MDA Tube for use with MA-D20 Attachment***Rx Only*** This…The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were… | 11/28/2012Terminated |
| Z-1893-2014 Class II | ANSPACH***REF 98-0031***Custom Medium Attachment, with 5 mm Extended Tapered Tip***Rx…The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were… | 11/28/2012Terminated |
| Z-1894-2014 Class II | ANSPACH***REF 98-0034***Custom XMax Motor, Pneumatic with Hand Control and Custom…The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were… | 11/28/2012Terminated |
| Z-1895-2014 Class II | ANSPACH***REF 98-0035***Custom eMax 2 Plus Motor with microMax Disconnect Sleeve***Rx…The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were… | 11/28/2012Terminated |
| Z-1896-2014 Class II | ANSPACH***REF 98-0037***Custom Device SC2102 with fast stop firmware***Rx Only*** This…The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were… | 11/28/2012Terminated |
| Z-1897-2014 Class II | ANSPACH***Custom XMax Motor, Pneumatic***Rx Only*** This device is intended to be used…The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were… | 11/28/2012Terminated |
| Z-1898-2014 Class II | ANSPACH***REF 98-0042***XMax Motor with Custom Hose***Rx Only*** This device is intended…The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were… | 11/28/2012Terminated |
| Z-1899-2014 Class II | ANSPACH***REF 98-0043***Custom Device eMax 2 Plus Hand Control that will work with a…The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were… | 11/28/2012Terminated |
| Z-1900-2014 Class II | ANSPACH***REF 98-0044***Custom Device Speed Reducer with Bumper***Rx Only*** This device…The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were… | 11/28/2012Terminated |
| Z-1901-2014 Class II | ANSPACH***REF 98-0048***Custom Circular ePLUS-FP***Rx Only*** This device is intended to…The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were… | 11/28/2012Terminated |
| Z-1902-2014 Class II | ANSPACH***Custom QD11 Attachment with thinner nose tube***Rx Only*** This device is…The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were… | 11/28/2012Terminated |
| Z-1903-2014 Class II | ANSPACH***REF-98-0056***Custom Device Autolube III modified with a swivel***Rx Only***…The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were… | 11/28/2012Terminated |
| Z-1904-2014 Class II | ANSPACH***REF-98-0062***Custom Device eMax2 Plus Hand Control***Rx Only*** This device…The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were… | 11/28/2012Terminated |
| Z-1905-2014 Class II | ANSPACH***REF SP-3012-00***13 mm Drill with Depth Stop for Short Heavy Duty…The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were… | 11/28/2012Terminated |