Z-1667-2016Class II

ANSPACH, Rx only, Otologic Curved Micro (OCCM) Diamond Ball Burr, 1.5 MM, Part # OCM7-15SD

Name: Z-1667-2016 ANSPACH, Rx only, Otologic Curved Micro (OCCM) Diamond Ball Burr, 1.5 MM, Part # OCM7-15SD
Creator: The Anspach Effort, Inc.
Published: 2016-03-28
License: https://open.fda.gov/license/

The Anspach Effort, Inc. / initiated 2016-03-28 / Terminated / root cause: manufacturing process

FDA source

The Anspach Effort, Inc. began a recall of ANSPACH, Rx only, Otologic Curved Micro (OCCM) Diamond Ball Burr, 1.5 MM, Part # OCM7-15SD Product Usage: The Otologic Curved Micro (OCCM) Attachment and burrs... on 2016-03-28. FDA classified it as Class II and gives the reason as "Certain lots of the Otologic Curved Micro (OCM) Diamond Ball Burrs may be missing the diamond coating and the ball may be the incorrect size". 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-1667-2016
Classification: Class II
Status: Terminated
Initiated: 2016-03-28
Posted: 2016-05-19
Terminated: 2016-12-14
Recalling firm: The Anspach Effort, Inc.
Product: ANSPACH, Rx only, Otologic Curved Micro (OCCM) Diamond Ball Burr, 1.5 MM, Part # OCM7-15SD Product Usage: The Otologic Curved Micro (OCCM) Attachment and burrs are intended for cutting and shaping bone primarily in otology procedures such as cochleostomies.
Product code: ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
Reason for recall: Certain lots of the Otologic Curved Micro (OCM) Diamond Ball Burrs may be missing the diamond coating and the ball may be the incorrect size.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Consignees were sent an Urgent Notice of this Medical Device Recall on 3/28/2016 for their product Otologic Curved Micro (OCM) Diamond Ball Burr, with the following actions required: We have record that your facility has the product(s) subject to this recall (removal). DePuy Synthes asks that you review your inventory and immediately remove the affected lots from stock. Please take the following actions: If you DO HAVE any of the identified devices, please take the following steps: Complete the Verification Section (page 3 of this letter) by checking the appropriate box indicating affected product has been located. Also, please indicate the number of devices found and note the Return Authorization Number. Please include your name, title, address, telephone number and signature in the spaces provided. Please contact Product Support at (800) 327-6887, option 1, to arrange for return of any unused product. A credit will be issued for returned product. Send a copy of the completed Verification Section (page 3) to Product Support by fax to (561) 627-2682. Send a copy of the completed Verification Section (page 3) to the Complaint Handling Unit by scan/email to [email protected]. If you DO NOT HAVE the identified product, please take the following steps: Complete the Verification Section by checking the appropriate box indicating that no affected product has been located. Please include your name, title, address, telephone number and signature in the spaces provided. This return documentation acknowledges your receipt of medical device recall (removal) information. Return the documents to The Anspach Effort by: Fax: (561) 627-2682 Scan/email: [email protected] Giving them to your DePuy Synthes Sales Consultant Note: If the Verification Section is answered on behalf of more than one facility and/or individual, please clearly indicate the name and address of the facility and/or individual of the notification.
Quantity in commerce: 27 devices
Distribution: US Distribution in the states of KY and TX.
Product codes and lots: Model/Catalog #:OCM7-15SD, 1.5 MM Diamond Ball, Lot Numbers: J473111704 and J473111705

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1667-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1667-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-25	2016-05-19
Z-1668-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-25	2016-05-19

Product code ERL

K131053Class IIAnspach Xmax, Emax2 and Emax2 Plus System with Otologic Attachment SystemThe Anspach Effort, Inc. / cleared 2013-12-31

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)