Z-2311-2015Class II
ANSPACH - 5MM Coarse Diamond Ball, 22MM Shaft Exposure; REF S-5DC-22-G1 Cutting shaping bone including spine...
The Anspach Effort, Inc. / initiated 2015-04-13 / Terminated / root cause: design
The Anspach Effort, Inc. began a recall of ANSPACH - 5MM Coarse Diamond Ball, 22MM Shaft Exposure; REF S-5DC-22-G1 Cutting shaping bone including spine and cranium on . FDA classified it as Class II and gives the reason as "G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product...". As of , the recall status on record is Terminated, and MDM tags the root cause as design.
Recall record
- Recall number
- Z-2311-2015
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- The Anspach Effort, Inc.
- Product
- ANSPACH - 5MM Coarse Diamond Ball, 22MM Shaft Exposure; REF S-5DC-22-G1 Cutting shaping bone including spine and cranium.
- Product code
- HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)
- Reason for recall
- G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft exposure may be greater.
- Root cause tag
- design
- FDA root cause
- Device Design
- Action
- Anspach sent an Urgent Notice: Medical Device Recall (Correction) letter of Anspach G1 Dissection Tools dated May 6, 2015, to all affected customers. Customers were not required to return their inventory of GI Dissection tools. Customers were instructed to complete, sign, and return the attached reply form confirming receipt of the letter by fax or email. Customers were also instructed to forward the letter as appropriate immediately. Customers with questions should contact the Complaint Handling Unit Manager at 561-494-3673 or contact their Anspach Sales Representative. For questions regarding this recall call 561-627-1080.
- Quantity in commerce
- 80 tools.
- Distribution
- Worldwide Distribution - US including AZ, CA, CO, FL, GA, IL, KY, LA, MN, MO, NC, NJ, NY, OH, OR, PA, TX, and Internationally to Canada and China.
- Product codes and lots
- REF S-5DC-22-G1 ; ALL lot numbers.
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2280-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2281-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2282-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2283-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2284-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2285-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2286-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2287-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2288-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2289-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2290-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2291-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2292-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2293-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2294-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2295-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2296-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2297-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2298-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2299-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2300-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2301-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2302-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2303-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2304-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2305-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2306-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2307-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2308-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2309-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2310-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2311-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2312-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2313-2015 | Class II | Terminated | Voluntary: Firm initiated |
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