Z-2783-2016Class I

Light Adaptor for Small Battery Drive and Small Battery Drive II

Name: Z-2783-2016 Light Adaptor for Small Battery Drive and Small Battery Drive II
Creator: The Anspach Effort, Inc.
Published: 2016-06-24
License: https://open.fda.gov/license/

The Anspach Effort, Inc. / initiated 2016-06-24 / Terminated / root cause: design

FDA source

The Anspach Effort, Inc. began a recall of Light Adaptor for Small Battery Drive and Small Battery Drive II on 2016-06-24. FDA classified it as Class I and gives the reason as "There was a potential for the Adaptor and Light Adaptor for Small Battery Drive and Small Battery Drive II to generate excessive internal pressure that may cause the products to burst". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2783-2016
Classification: Class I
Status: Terminated
Initiated: 2016-06-24
Posted: 2016-09-27
Terminated: 2018-06-09
Recalling firm: The Anspach Effort, Inc.
Product: Light Adaptor for Small Battery Drive and Small Battery Drive II.
Product code: HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
Reason for recall: There was a potential for the Adaptor and Light Adaptor for Small Battery Drive and Small Battery Drive II to generate excessive internal pressure that may cause the products to burst.
Root cause tag: design
FDA root cause: Device Design
Action: An Urgent Notice for this Recall was provided to the consignees on 6/24/2016. They were to review their inventory and return the products with instructions. IF YOU HAVE ANY PRODUCT: To immediately quarantine product so it's not used; ensure all in their facility read the Urgent Notice for the Recall; Call the DePuy Synthes Customer Support to obtain a Return Materials Authorization (RMA) Number; to complete the Verification Section indicating the product subject to recall was located; to return the Verification Section with the product to Product Returns, The Anspach Effort Inc., 4500 Riverside Drive, Palm Beach Gardens, FL 33410; Send a copy of the completed Verification Section to DePuy Synthes, Customer Quality Dept by: FAX (561) 627-2682 or Scan/email: [email protected]; Keep the notice visibly posted for awareness until all products have been returned; maintain a copy of the notice subject to this action and keep a copy for your records. The return documentation acknowledges your receipt of the medical device removal information. IF YOU DO NOT HAVE the identified product: complete the Verification Section of the recall, by checking the box indicating no affected product located; Include your name title, address, telephone #, signature and date; Send a copy of the completed Verification Section to DePuy Synthes Customer Quality Dept by: Fax: (561) 627-2682, or Scan/e-mail: [email protected]; This return document acknowledges your receipt of medical device removal information; ADVISORY: For Alternative products: This product does not have any inventory for replacement. Since the recall of this device may have an impact on your surgical schedule, DePuy Synthes Power Tools would like to propose alternative products to assist you with a replacement for the Recalled Adaptor (05.100.024) or Light Adaptor (05.001.108) . The products are the Small Battery Drive II Hand-piece (532.110) can also be operated
Quantity in commerce: 1,833 devices (05.001.024 and 05.001.108)
Distribution: Worldwide Distribution - US Nationwide and including the countries of Canada, Austria, Australia, Belgium, Brazil, Chile, China, Colombia, Costa Rica, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Libya, Malaysia, Mexico, Nepal, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovenia, Slovakia, Spain, South Africa, South Korea, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, and Vietnam, and areas of Middle East, Africa, Asia & Pacific.
Product codes and lots: Model/Catalog: Part # (05.001.108 and 05.001.024) Serial: All Serial Numbers.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2783-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2783-2016	Class I	Terminated	Voluntary: Firm initiated	2016-10-05	2016-09-26
Z-2784-2016	Class I	Terminated	Voluntary: Firm initiated	2016-10-05	2016-09-26

Product code HWE

K043310Class ISynthes (USA) Electric Pen Drive SystemSynthes (Usa) / cleared 2005-01-05

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)