Z-1962-2016Class II

BioSync Anatomic Cotton Wedge, 20 x 5.5 mm.; Used for internal bone fixation for bone fractures, fusions or...

Name: Z-1962-2016 BioSync Anatomic Cotton Wedge, 20 x 5.5 mm.; Used for internal bone fixation for bone fractures, fusions or...
Creator: Arthrex, Inc.
Published: 2016-04-22
License: https://open.fda.gov/license/

Arthrex GmbH / initiated 2016-04-22 / Terminated / root cause: manufacturing process

FDA source

Arthrex, Inc. began a recall of BioSync Anatomic Cotton Wedge, 20 x 5.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot on 2016-04-22. FDA classified it as Class II and gives the reason as "Potential for polystyrene particulate presence". 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-1962-2016
Classification: Class II
Status: Terminated
Initiated: 2016-04-22
Posted: 2016-06-14
Terminated: 2017-10-13
Recalling firm: Arthrex GmbH
Product: BioSync Anatomic Cotton Wedge, 20 x 5.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.
Product code: PLF Bone Wedge
Reason for recall: Potential for polystyrene particulate presence.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: On 04/22/2016 Arthrex contacted all distributors that received potentially affected devices and instructed them to place the product in quarantine. Distributors were then instructed to return affected devices to Arthrex. Surgeons who have implanted the device will also be receiving a recall notification. Surgeons, risk managers, and distributors received mailed recall notification identifying the recalled products and batches, the reason for recall, and instructions for returning affected product. Customers are to call Arthrex's Customer Service Line (800-934-4404) to obtain return authorization and further instructions. Customers were also required to complete a "Recall Acknowledgement of Receipt" postal card to return to Arthrex, Inc. in an enclosed envelope.
Quantity in commerce: 138 products total
Distribution: Distributed in the states of CA, CO, FL, GA, IL, IN, KS, MD, NC, NY, PA, SC, VA, WA, and WI.
Product codes and lots: Catalog #: AR-8948W-2055; Batch #: 10019817; Unique Device Identifier: 00888867202740.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1962-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1958-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-22	2016-06-14
Z-1959-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-22	2016-06-14
Z-1960-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-22	2016-06-14
Z-1961-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-22	2016-06-14
Z-1962-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-22	2016-06-14
Z-1963-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-22	2016-06-14

Product code PLF

K151256Class IIArthrex BioSync® Bone WedgeArthex, Inc. / cleared 2015-08-12

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)