Data Foundry

Medical device recalls 2015

Synthes Small Battery Drive — Class II medical device recall Z-1553-2015

Terminated recall by The Anspach Effort, Inc., reported 2015-05-06, distributed nationwide. The potential exists for the Oscillating Saw Attachment to disengage from the Small Battery Drive handpiece. I

Recall numberZ-1553-2015
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmThe Anspach Effort, Inc., Palm Beach Gardens, FL, United States
Recall initiated2015-03-24
Classified2015-04-30
Reported by FDA2015-05-06
Terminated2016-12-14
DistributedNationwide (US)
Countries outside the USAE, AR, AT, AU, BE, BH, BO, BR, CA, CL, CN, CR, CZ, DE, DK, EC, EG, ES, FI, FR, GB, GR, GT, HK, HR, HU, ID, IE, IL, IN, IQ, IR, IT, JO, JP, KE, KR, KW, LB, LK, MA, MX, MY, NL, NO, NP, NZ, OM, PE, PH, PT, RO, RS, SA, SE, SG, SI, SK, SV, TH, TR, TW, UA, UY, VE, VN, ZA
Quantity12,085 units
Model numbers532.021

Product

Synthes Small Battery Drive (SBD) Oscillating Saw Attachment Part Number: 532.021 for orthopedic surgery.

Reason for recall

The potential exists for the Oscillating Saw Attachment to disengage from the Small Battery Drive handpiece. If the attachment disengages from the handpiece intra-operatively, there is a potential for injury to the patient and/or user.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1553-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.