Z-2608-2016Class II

Conical portio adapter (acorn) small & large are used for examination and diagnosis in conjunction with...

Name: Z-2608-2016 Conical portio adapter (acorn) small & large are used for examination and diagnosis in conjunction with...
Creator: Richard Wolf Medical Instruments Corp.
Published: 2016-05-19
License: https://open.fda.gov/license/

Richard Wolf Medical Instruments Corp. / initiated 2016-05-19 / Terminated / root cause: manufacturing process

FDA source

Richard Wolf Medical Instruments Corp. began a recall of Conical portio adapter (acorn) small & large are used for examination and diagnosis in conjunction with endoscopic accessories in gynecological laparoscopy, to... on 2016-05-19. FDA classified it as Class II and gives the reason as "The distal end of the Conical portio adapter (acorn) is composed of a small cap (head) that partially sits inside a hollow shaft (tube). These two parts are welded together to create one piece. In the impacted batches...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2608-2016
Classification: Class II
Status: Terminated
Initiated: 2016-05-19
Posted: 2016-08-19
Terminated: 2017-11-30
Recalling firm: Richard Wolf Medical Instruments Corp.
Product: Conical portio adapter (acorn) small & large are used for examination and diagnosis in conjunction with endoscopic accessories in gynecological laparoscopy, to determine patency of the fallopian tubes.
Product code: HHI System, Abortion, Vacuum
Reason for recall: The distal end of the Conical portio adapter (acorn) is composed of a small cap (head) that partially sits inside a hollow shaft (tube). These two parts are welded together to create one piece. In the impacted batches of product, the weld was improperly performed. As a result, the two pieces are not properly joined. This potential failure can result in the separation of the two pieces. The possible separation of these two components presents a potential risk to patients.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Customers impacted were notified via Urgent Medical Device Recall Letter dated 5/31/2016 via certified mail. The letter describes the reason for the recall. Richard Wolf Identified the following measures to be taken by the consignees: 1. Immediately examine your inventory and quarantine product subject to recall. Richard Wolf Medical Instruments Corporation strongly recommends not using the potentially defective products. Please make sure that all users of the aforementioned products become aware of this urgent safety information. 2. If you have further distributed this product, please identify your customers and immediately notify them about this product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter, but must include instructions on what customers should do with the recalled product. 3. PLEASE COMPLETE ENCLOSED ANSWER FORM {even if the product is no longer in your inventory) and return the record to Richard Wolf Medical Instruments Corporation before June 17, 2016. Your return of the answer form will: " Confirm receipt of this safety information " Trigger a replacement order. Richard Wolf Medical Instruments Corporation will provide your facility with a return authorization number and shipping instructions and will bear the cost for shipping (returns to RWMIC and replacements to facility). 4. Please immediately inform Richard Wolf Medical Instruments Corporation of any adverse events. If the consignees have any questions they are asked to contact Lisa Williams, Regulatory Affairs Assistant at Richard Wolf Medical Instruments Corporation Richard Wolf Medical Instruments Corporation. Telephone: (847) 913-1113 Ext: 256 Telephone: (847) 913-1113 Ext: 225 Fax: (847) 913-0924 Fax: (847) 913-0924 Email : [email protected] Monday through Friday, 7:30AM to 4:00 PM CST. Monday through Friday, 9:00AM to 5:30 PM
Quantity in commerce: Product code 8378.90- 94 pieces & Product code 8378.91 - 32 pieces
Distribution: U.S. Consignees: AK, AL, AR, AZ, CA, CT, DC, FL, GA, IA, IL, KY, MA, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OR, TX, UT and VA.
Product codes and lots: Product number 8378.90 with Batch number 51005921 and Product number 8378.91 with Batch number 51005922

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2608-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2608-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-31	2016-08-19

Product code HHI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)